Trial Outcomes & Findings for A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression (NCT NCT00141271)
NCT ID: NCT00141271
Last Updated: 2021-03-25
Results Overview
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.
COMPLETED
PHASE3
536 participants
Baseline to 6 weeks
2021-03-25
Participant Flow
56 centers in the US
7-day washout:psychotropic drugs \& lithium. 4-week washout: monoamine oxidase inhibitors, fluoxetine alone or in combination with olanzapine. Depot neuroleptic Discontinued (DC'd) 6 mo prior to entry. 536 subjects enrolled: 504 assigned to drug; 32 not assigned:18 lost to follow up, 5 DC'd study, 9 didn't take/receive study drug for other reasons.
Participant milestones
| Measure |
120-160mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
Subjects were assigned to placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
171
|
165
|
168
|
|
Overall Study
COMPLETED
|
91
|
102
|
111
|
|
Overall Study
NOT COMPLETED
|
80
|
63
|
57
|
Reasons for withdrawal
| Measure |
120-160mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
Subjects were assigned to placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
31
|
19
|
17
|
|
Overall Study
Laboratory Abnormality
|
2
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
7
|
7
|
3
|
|
Overall Study
Lost to Follow-up
|
15
|
15
|
21
|
|
Overall Study
Withdrawal by Subject
|
14
|
9
|
10
|
|
Overall Study
Other
|
11
|
12
|
5
|
Baseline Characteristics
A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression
Baseline characteristics by cohort
| Measure |
120-160mg Ziprasidone
n=171 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=165 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=168 Participants
Subjects were assigned to placebo
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
39.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 11.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
284 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksPopulation: Intent to treat (ITT) population observed cases
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 1 (n=161, 153, 159)
|
-6.07 score on scale
Standard Error 0.62
|
-7.66 score on scale
Standard Error 0.73
|
-5.75 score on scale
Standard Error 0.65
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 2 (n=135, 142, 146)
|
-10.12 score on scale
Standard Error 0.79
|
-10.20 score on scale
Standard Error 0.82
|
-9.47 score on scale
Standard Error 0.77
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 3 (n=120, 131, 138)
|
-11.61 score on scale
Standard Error 0.88
|
-12.93 score on scale
Standard Error 0.85
|
-11.37 score on scale
Standard Error 0.81
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 4 (n=106, 126, 131)
|
-12.54 score on scale
Standard Error 0.88
|
-13.87 score on scale
Standard Error 0.91
|
-12.49 score on scale
Standard Error 0.82
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 5 (n=99, 115, 123)
|
-14.25 score on scale
Standard Error 0.94
|
-14.53 score on scale
Standard Error 0.90
|
-12.99 score on scale
Standard Error 0.97
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 6 (n=95, 107, 115)
|
-13.81 score on scale
Standard Error 1.02
|
-14.77 score on scale
Standard Error 0.97
|
-13.25 score on scale
Standard Error 1.00
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Overall (n=166, 158, 162)
|
-11.40 score on scale
Standard Error 0.73
|
-12.33 score on scale
Standard Error 0.74
|
-10.89 score on scale
Standard Error 0.72
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: Intent to treat (ITT) population observed cases. Not all subjects answered at each Week
Participants with MADRS Total Score greater or equal to 50 percent decrease from baseline responded yes; others responded no. Endpoint is last observation carried forward (LOCF) among Week 1 - Week 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6 (most abnormal). Total possible score is 0 - 60
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 1: Yes
|
19 Participants
|
32 Participants
|
26 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 1: No
|
142 Participants
|
121 Participants
|
133 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 2 : Yes
|
51 Participants
|
50 Participants
|
51 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 2: No
|
84 Participants
|
92 Participants
|
95 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 3: Yes
|
57 Participants
|
67 Participants
|
60 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 3: No
|
63 Participants
|
64 Participants
|
78 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 4: Yes
|
56 Participants
|
70 Participants
|
68 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 4: No
|
50 Participants
|
56 Participants
|
63 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 5: Yes
|
67 Participants
|
74 Participants
|
71 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 5: No
|
32 Participants
|
41 Participants
|
52 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 6: Yes
|
58 Participants
|
69 Participants
|
67 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Week 6: No
|
37 Participants
|
38 Participants
|
48 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Endpoint: Yes
|
76 Participants
|
83 Participants
|
80 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS)Total Score
Endpoint: No
|
90 Participants
|
75 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6 Not all subjects answered each Week.
Participants with greater than or equal to 50 percent decrease from baseline in HAMD-17 total score responded yes; others responded no. Endpoint is LOCF endpoint among Week 1 - 6; Total score is first 17 items of HAM-D 25: measures range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 3: Yes
|
60 participants
|
67 participants
|
61 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 3: No
|
87 participants
|
82 participants
|
87 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 6: Yes
|
64 participants
|
73 participants
|
73 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 6: No
|
40 participants
|
44 participants
|
52 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Endpoint: Yes
|
74 participants
|
82 participants
|
81 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Endpoint: No
|
77 participants
|
68 participants
|
72 participants
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases, Last Observation Carried Forward (LOCF).
Change is observed value at endpoint minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 - 6; GAF is used to assess global psychological, social, \& occupational functioning; 100=normal and 0=greatest abnormality
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Global Assessment of Functioning (GAF)at Endpoint, Last Observation Carried Forward (LOCF)
|
10.11 score on scale
Standard Error 1.38
|
11.72 score on scale
Standard Error 1.37
|
11.19 score on scale
Standard Error 1.40
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6; Not all subjects answered each week.
Response was Yes if MADRS Total Score was less than, equal to 12, if not, response was no. Endpoint is LOCF endpoint among Week 1 through 6; MADRS is 10-item instrument measuring depression; scale range 0(Normal) and 6(most abnormal)
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 1; Yes
|
18 participants
|
27 participants
|
25 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 1; No
|
143 participants
|
126 participants
|
134 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 2; Yes
|
48 participants
|
41 participants
|
44 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 2; No
|
87 participants
|
101 participants
|
102 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 3; Yes
|
56 participants
|
61 participants
|
55 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 3; No
|
64 participants
|
70 participants
|
83 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 4; Yes
|
55 participants
|
65 participants
|
66 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 4; No
|
51 participants
|
61 participants
|
65 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 5; Yes
|
65 participants
|
66 participants
|
66 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 5; No
|
34 participants
|
49 participants
|
57 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 6; Yes
|
58 participants
|
63 participants
|
61 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Week 6; No
|
37 participants
|
44 participants
|
54 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Endpoint; Yes
|
73 participants
|
72 participants
|
73 participants
|
|
Remission as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Less Than or Equal to 12
Endpoint; No
|
93 participants
|
86 participants
|
89 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT Observed Cases.Endpoint is LOCF endpoint among Week 1 through Week 6 Not all subjects answered each week.
Response was yes when HAM-D 17 total score was less than or equal to 7 , if not, response was no. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25,which measures the range of depressive symptoms; scale 0-2 or 0-4 with higher scores being more severe. Total possible score 0 - 52.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Week 3; Yes
|
27 Participants
|
30 Participants
|
35 Participants
|
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Week 3; No
|
120 Participants
|
119 Participants
|
113 Participants
|
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Week 6; Yes
|
41 Participants
|
43 Participants
|
43 Participants
|
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Week 6; No
|
63 Participants
|
74 Participants
|
82 Participants
|
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Endpoint: Yes
|
45 Participants
|
44 Participants
|
47 Participants
|
|
Remission as Measured by Hamilton Depression (HAM-D 17) Total Score Less Than or Equal to 7
Endpoint: No
|
106 Participants
|
106 Participants
|
106 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Total score is first 17 items of the HAM-D 25, which measures the range of depressive symptoms patient currently experiencing; scale 0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score 0 - 52.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Hamilton Depression (HAM-D 17) Total Score
Week 3 (n= 147, 149, 148)
|
-9.56 score on scale
Standard Error 0.82
|
-10.58 score on scale
Standard Error 0.81
|
-10.13 score on scale
Standard Error 0.82
|
|
Change in Hamilton Depression (HAM-D 17) Total Score
Week 6 (n= 104,117,125)
|
-12.37 score on scale
Standard Error 1.12
|
-12.82 score on scale
Standard Error 1.06
|
-11.30 score on scale
Standard Error 1.06
|
|
Change in Hamilton Depression (HAM-D 17) Total Score
Endpoint (n= 151,150,153)
|
-10.48 score on scale
Standard Error 0.95
|
-11.48 score on scale
Standard Error 0.95
|
-10.60 score on scale
Standard Error 0.95
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. HAM-A is a 14-item scale: rates intensity of psychic anxiety and somatic anxiety on a 5-point severity scale (range: 0=not present to 4=very severe). Total possible score is 0 - 56.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Hamilton Anxiety Rating (HAM-A)
Week 3 (n= 147, 148, 147)
|
-5.54 score on scale
Standard Error 0.74
|
-6.46 score on scale
Standard Error 0.74
|
-6.79 score on scale
Standard Error 0.74
|
|
Change in Hamilton Anxiety Rating (HAM-A)
Week 6 (n= 104, 117, 124)
|
-7.63 score on scale
Standard Error 0.94
|
-7.46 score on scale
Standard Error 0.89
|
-6.73 score on scale
Standard Error 0.89
|
|
Change in Hamilton Anxiety Rating (HAM-A)
Endpoint (n= 151, 150, 152)
|
-6.40 score on scale
Standard Error 0.81
|
-6.75 score on scale
Standard Error 0.81
|
-6.82 score on scale
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT Population
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. YMRS: 11 item instrument with scale 0 to 4 for 7 items and 0 to 8 for 4 items; 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 1 (n = 140,131, 132)
|
0.05 score on scale
Standard Error 0.34
|
0.64 score on scale
Standard Error 0.41
|
-0.08 score on scale
Standard Error 0.33
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 2 (n = 114,124,123)
|
0.16 score on scale
Standard Error 0.38
|
0.64 score on scale
Standard Error 0.41
|
0.51 score on scale
Standard Error 0.37
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 3 (n = 120, 130, 138)
|
-0.03 score on scale
Standard Error 0.44
|
0.11 score on scale
Standard Error 0.39
|
0.05 score on scale
Standard Error 0.40
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 4 (n = 93, 116, 116)
|
-0.09 score on scale
Standard Error 0.43
|
0.19 score on scale
Standard Error 0.49
|
-0.73 score on scale
Standard Error 0.41
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 5 (n = 87, 105, 109)
|
-0.89 score on scale
Standard Error 0.43
|
-0.82 score on scale
Standard Error 0.43
|
-0.28 score on scale
Standard Error 0.45
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 6 (n = 95, 107, 115)
|
-0.86 score on scale
Standard Error 0.42
|
-0.03 score on scale
Standard Error 0.50
|
-1.00 score on scale
Standard Error 0.42
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Overall (n = 161, 158, 161)
|
-0.27 score on scale
Standard Error 0.33
|
0.12 score on scale
Standard Error 0.36
|
-0.26 score on scale
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT population Observed Cases
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-S measures severity of patient's mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Week 4 (n=105, 126, 130)
|
-1.14 score on scale
Standard Error 0.11
|
-1.23 score on scale
Standard Error 0.11
|
-1.14 score on scale
Standard Error 0.10
|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Week 5 (n=98, 115, 123)
|
-1.33 score on scale
Standard Error 0.11
|
-1.35 score on scale
Standard Error 0.12
|
-1.23 score on scale
Standard Error 0.11
|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Week 1 (n=161, 152, 158)
|
-0.05 score on scale
Standard Error 0.08
|
-0.47 score on scale
Standard Error 0.07
|
-0.42 score on scale
Standard Error 0.07
|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Week 2 (n=133, 142, 147)
|
-0.84 score on scale
Standard Error 0.09
|
-0.82 score on scale
Standard Error 0.09
|
-0.75 score on scale
Standard Error 0.09
|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Week 3 (n=119, 131, 137)
|
-0.90 score on scale
Standard Error 0.11
|
-1.15 score on scale
Standard Error 0.10
|
-0.93 score on scale
Standard Error 0.09
|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Week 6 (n=94, 107, 115)
|
-1.38 score on scale
Standard Error 0.12
|
-1.38 score on scale
Standard Error 0.12
|
-1.35 score on scale
Standard Error 0.12
|
|
Change in Assessment of Global Clinical Severity of Symptoms (CGI-S)
Overall (n=165, 158, 162)
|
-1.02 score on scale
Standard Error 0.09
|
-1.07 score on scale
Standard Error 0.09
|
-0.97 score on scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT population Observed Cases
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. CGI-I is an instrument for Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 3 (n=120,131,137)
|
2.90 score on scale
Standard Error 0.13
|
2.62 score on scale
Standard Error 0.11
|
2.83 score on scale
Standard Error 0.10
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 4 (n=106,126,130)
|
2.54 score on scale
Standard Error 0.11
|
2.53 score on scale
Standard Error 0.11
|
2.55 score on scale
Standard Error 0.10
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 5 (n=99, 115, 123)
|
2.47 score on scale
Standard Error 0.12
|
2.48 score on scale
Standard Error 0.12
|
2.59 score on scale
Standard Error 0.12
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 6 (n=95,107, 115)
|
2.49 score on scale
Standard Error 0.13
|
2.43 score on scale
Standard Error 0.13
|
2.52 score on scale
Standard Error 0.12
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Overall (n=166, 158, 162)
|
2.77 score on scale
Standard Error 0.10
|
2.67 score on scale
Standard Error 0.09
|
2.81 score on scale
Standard Error 0.09
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 1 (n=162, 152, 158)
|
3.34 score on scale
Standard Error 0.09
|
3.17 score on scale
Standard Error 0.09
|
3.38 score on scale
Standard Error 0.09
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 2 (n=134, 142, 147)
|
2.86 score on scale
Standard Error 0.11
|
2.82 score on scale
Standard Error 0.10
|
3.01 score on scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksPopulation: ITT Population Observed Cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change: observed value at each visit minus baseline value. Endpoint is Last Observation Carried Forward (LOCF) endpoint among Week 1 through Week 6. HAM-D 25: measures the range of depressive symptoms experienced. 25 Items with Scale range:0-2 or 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme.Total possible score is 0 - 72.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Total Score in Hamilton Depression (HAM-D 25)
Week 3 (n= 147, 149, 147)
|
-11.02 score on scale
Standard Error 0.98
|
-12.16 score on scale
Standard Error 0.97
|
-12.25 score on scale
Standard Error 0.98
|
|
Change in Total Score in Hamilton Depression (HAM-D 25)
Week 6 (n= 104, 117, 125)
|
-14.59 score on scale
Standard Error 1.32
|
-15.08 score on scale
Standard Error 1.25
|
-13.74 score on scale
Standard Error 1.24
|
|
Change in Total Score in Hamilton Depression (HAM-D 25)
Endpoint (n= 151, 150, 153)
|
-12.25 score on scale
Standard Error 1.11
|
-13.36 score on scale
Standard Error 1.11
|
-12.78 score on scale
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Week 1 through Week 6 (endpoint)Population: ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6. Not all subjects answered each week.
Response each week was yes if CGI-I score less than or equal to 2 (much or very much improved), if not, response was no; Endpoint is LOCF endpoint among Week 1 through Week 6. CGI-I is a Global assessment of improvement in patient's condition. Scale range: 0=not assessed, 1=very much improved, 7=very much worse
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 6; Yes
|
60 Participants
|
76 Participants
|
66 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 1; Yes
|
20 Participants
|
34 Participants
|
28 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 1; No
|
142 Participants
|
118 Participants
|
130 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 2; Yes
|
52 Participants
|
54 Participants
|
50 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 2; No
|
82 Participants
|
88 Participants
|
97 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 3; Yes
|
51 Participants
|
71 Participants
|
58 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 3; No
|
69 Participants
|
60 Participants
|
79 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 4; Yes
|
68 Participants
|
76 Participants
|
70 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 4; No
|
38 Participants
|
50 Participants
|
60 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 5; Yes
|
69 Participants
|
74 Participants
|
73 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 5; No
|
30 Participants
|
41 Participants
|
50 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Week 6; No
|
35 Participants
|
31 Participants
|
49 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Endpoint; Yes
|
74 Participants
|
83 Participants
|
77 Participants
|
|
Response as Measured by CGI-I Score Less Than or Equal to 2
Endpoint; No
|
92 Participants
|
75 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: ITT Population Observed cases. Endpoint is LOCF endpoint among Week 1 - 6; n= 128, 126, 128; number of subjects who responded to the scale.
Observed value each visit minus baseline value. Endpoint is LOCF Week 1 through Week 6. SDS: patient rated measure of disability and impairment in 3 items: work/school, social life, family life/home responsibilities:0(no disruption)- 10(extreme disruption). Total possible is 30.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Sheehan Disability Scale (SDS) Total Score at Endpoint
|
-5.78 score on scale
Standard Error 1.01
|
-5.43 score on scale
Standard Error 1.02
|
-6.79 score on scale
Standard Error 1.02
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksPopulation: ITT Population Observed Cases.n= 142, 137, 139; number of subjects who responded to the scale. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. LOCF endpoint among Week 1 through Week 6. Q-LES-Q: 16-item instrument for patients assessment of his/her quality of life; overall level of satisfaction scale 1=very poor to 5=Very good (1 item re medication can be blank). Total possible score 15 - 80
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score at Endpoint
|
0.08 score on scale
Standard Error 0.02
|
0.09 score on scale
Standard Error 0.02
|
0.09 score on scale
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksPopulation: ITT Population Observed cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Bech Melancholia is the sum of Scores on 6 Items pertaining to melancholia within Hamilton Depression Rating Scale (HAM-D). Scale 0 to 4, higher scores reflecting greater severity;Total possible 0 - 24.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Bech Melancholia Score
Week 3 (n = 147, 149, 148)
|
-5.12 score on scale
Standard Error 0.47
|
-5.61 score on scale
Standard Error 0.47
|
-5.22 score on scale
Standard Error 0.47
|
|
Change in Bech Melancholia Score
Week 6 (n = 104, 117, 125)
|
-6.91 score on scale
Standard Error 0.65
|
-6.93 score on scale
Standard Error 0.62
|
-6.23 score on scale
Standard Error 0.61
|
|
Change in Bech Melancholia Score
Endpoint (n =151, 150, 153)
|
-5.85 score on scale
Standard Error 0.54
|
-6.23 score on scale
Standard Error 0.54
|
-5.70 score on scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksPopulation: ITT Population Observed Cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores on 6 Items measuring anxiety/somatization within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4, higher scores reflecting greater severity. Total possible 0 - 24.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Anxiety/Somatizations Factor Total Score
Week 3 (n = 147,149,148)
|
-2.69 score on scale
Standard Error 0.30
|
-2.92 score on scale
Standard Error 0.30
|
-2.98 score on scale
Standard Error 0.30
|
|
Change in Anxiety/Somatizations Factor Total Score
Week 6 (n = 104,117,125)
|
-3.67 score on scale
Standard Error 0.40
|
-3.88 score on scale
Standard Error 0.38
|
-3.62 score on scale
Standard Error 0.38
|
|
Change in Anxiety/Somatizations Factor Total Score
Endpoint (n = 151,150,153)
|
-3.04 score on scale
Standard Error 0.34
|
-3.39 score on scale
Standard Error 0.34
|
-3.32 score on scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline to 6 WeeksChange is observed value at each visit minus baseline value. This instrument = sum of Scores of 4 items on retardation within Hamilton Depression Rating Scale (HAM-D). Scale range is 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 16.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Retardation Factor Scores
Endpoint (n = 151,150,153)
|
-3.89 score on scale
Standard Error 0.35
|
-3.99 score on scale
Standard Error 0.35
|
-3.62 score on scale
Standard Error 0.35
|
|
Change in Retardation Factor Scores
Week 3 (n = 147,149,148)
|
-3.50 score on scale
Standard Error 0.32
|
-3.64 score on scale
Standard Error 0.32
|
-3.59 score on scale
Standard Error 0.33
|
|
Change in Retardation Factor Scores
Week 6 (n = 104,117,125)
|
-4.44 score on scale
Standard Error 0.42
|
-4.40 score on scale
Standard Error 0.40
|
-3.79 score on scale
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Baseline to 6 weeksPopulation: ITT Population Observed cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument = sum of Scores of 3 items on sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible is 0 - 12.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Sleep Disturbance Factor Score
Week 3 (n = 147, 149, 148)
|
-1.92 score on scale
Standard Error 0.24
|
-2.07 score on scale
Standard Error 0.23
|
-1.96 score on scale
Standard Error 0.24
|
|
Change in Sleep Disturbance Factor Score
Week 6 (n = 104, 117, 125)
|
-2.20 score on scale
Standard Error 0.30
|
-2.19 score on scale
Standard Error 0.28
|
-2.06 score on scale
Standard Error 0.28
|
|
Change in Sleep Disturbance Factor Score
Endpoint (n = 151, 150 153)
|
-1.90 score on scale
Standard Error 0.24
|
-1.98 score on scale
Standard Error 0.24
|
-1.96 score on scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to Treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is part of Brief Assessment of Cognition and measures recall of 15 words repeated 5 times. Range 0-75 words, higher number reflects better recall.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Verbal Memory Trial Performance Total Score at Endpoint
|
1.31 words
Standard Error 0.97
|
0.85 words
Standard Error 0.96
|
1.22 words
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition measuring immediate recall of 15 emotional words; higher number of words is better recall.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test Immediate Recall List 1 Emotional Words at Endpoint
|
-0.28 words
Standard Error 0.15
|
-0.30 words
Standard Error 0.15
|
-0.06 words
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This instrument measures immediate recall of 15 non-emotional words (List 1); higher number of words is better recall.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test Immediate Recall Non-Emotional Words List 1 at Endpoint
|
-0.02 words
Standard Error 0.15
|
0.14 words
Standard Error 0.15
|
-0.00 words
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This test is in Brief Assessment of Cognition and measures immediate recall of 15 emotional words (List 2); higher number of words is better recall
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Immediate Recall, List 2 Emotional Words at Endpoint
|
-0.09 words
Standard Error 0.19
|
-0.05 words
Standard Error 0.19
|
0.05 words
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 2); higher number of words is better recall
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Immediate Recall, List 2 Non-Emotional Words at Endpoint
|
-0.16 words
Standard Error 0.19
|
0.07 words
Standard Error 0.19
|
0.13 words
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCFPopulation: Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 emotional words (List 3); higher number of words is better recall
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Immediate Recall, List 3 Emotional Words at Endpoint
|
-0.18 words
Standard Error 0.21
|
-0.30 words
Standard Error 0.20
|
-0.03 words
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCFPopulation: Intent to treat (ITT) population observed cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall of 15 non-emotional words (List 3); higher number of words is better recall
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Immediate Recall, List 3 Non-Emotional Words at Endpoint
|
-0.52 words
Standard Error 0.19
|
-0.15 words
Standard Error 0.19
|
-0.24 words
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 non-emotional words; higher number of words is better recall
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Immediate Recall, Cued-Recall Non-Emotional Words at Endpoint
|
-0.39 words
Standard Error 0.18
|
-0.01 words
Standard Error 0.18
|
-0.32 words
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures immediate recall (Cued) of 15 emotional words; higher number of words is better recall
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Immediate Recall, Cued-Recall Emotional Words at Endpoint
|
-0.06 words
Standard Error 0.20
|
-0.07 words
Standard Error 0.20
|
0.08 words
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which patient sequences digits from lowest to highest. Range of number of correct responses (0-28); higher numbers show better digit sequencing and greater cognition.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Digit Sequencing Task at Endpoint
|
0.76 Number Correct
Standard Error 0.37
|
0.09 Number Correct
Standard Error 0.37
|
0.46 Number Correct
Standard Error 0.38
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition in which a patient places as many of 100 tokens (2 at a time) into a container as they can within 60 seconds. The higher number of tokens placed = patient is better at motor tasks
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Token Motor Task at Endpoint
|
0.28 Number of Tokens
Standard Error 1.54
|
-0.00 Number of Tokens
Standard Error 1.53
|
2.02 Number of Tokens
Standard Error 1.57
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases.Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition.Patients are given 60 seconds to name as many words as possible within a given category. The more words named=better cognition.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Verbal Fluency in Naming Categories at Endpoint
|
0.19 Number Correct
Standard Error 0.58
|
-0.11 Number Correct
Standard Error 0.58
|
-0.28 Number Correct
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. Patients given 60 seconds to generate as many words as possible that begin with a given letter; better verbal fluency = more words
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Verbal Fluency Controlled Word Association at Endpoint
|
1.09 Number Correct
Standard Error 0.67
|
-0.15 Number Correct
Standard Error 0.66
|
1.54 Number Correct
Standard Error 0.69
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition. For 90 seconds, Patient writes numerals 1-9 as matched to symbols. Range 0 to 110 with higher totals = better cognition.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Symbol Coding at Endpoint
|
1.34 Total Correct
Standard Error 1.18
|
1.07 Total Correct
Standard Error 1.16
|
2.66 Total Correct
Standard Error 1.21
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint: LOCF endpoint among Week 1 through Week 6. Brief Assessment of Cognition: subjects asked to arrange balls in 2 pictures so they are identical and give the total number of ball movements to reach this arrangment. Range: 0-22; more correct = better cognition.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Tower of London Test at Endpoint
|
0.31 Number Correct
Standard Error 0.41
|
0.68 Number Correct
Standard Error 0.41
|
0.91 Number Correct
Standard Error 0.43
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition in which the number of correct emotional words in delayed recognition is measured. Range 0-75 with higher numbers showing better cognition.
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Delayed Recognition, Emotional Words at Endpoint
|
-0.37 Words
Standard Error 0.22
|
0.15 Words
Standard Error 0.22
|
0.23 Words
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline to 6 Weeks LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. Test in Brief Assessment of Cognition which measures number of correct emotional word's false alarms (during delayed recognition). Higher number = better cognition
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Delayed Recognition, Emotional Words False Alarms at Endpoint
|
0.09 Number Correct
Standard Error 0.10
|
0.01 Number Correct
Standard Error 0.10
|
-0.03 Number Correct
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of Non-Emotional Words (Delayed Recognition); higher number of words = better cognition
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words at Endpoint
|
-0.18 Number Correct
Standard Error 0.23
|
-0.24 Number Correct
Standard Error 0.23
|
-0.02 Number Correct
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline to Week 6 LOCFPopulation: Intent to treat (ITT) population observed cases. Endpoint is LOCF endpoint among Week 1 through Week 6.
Change is observed value at each visit minus baseline value. Endpoint is LOCF endpoint among Week 1 through Week 6. This is a test in Brief Assessment of Cognition which measures number of correct non-eEmotional word's false alarms(at delayed recognition). Higher number of words = greater cognition
Outcome measures
| Measure |
120-160mg Ziprasidone
n=166 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
n=158 Participants
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
n=162 Participants
Subjects were assigned to placebo
|
|---|---|---|---|
|
Change in Affective Interference Test, Delayed Recognition, Non-Emotional Words False Alarms at Endpoint
|
0.06 Number Correct
Standard Error 0.15
|
0.19 Number Correct
Standard Error 0.15
|
0.14 Number Correct
Standard Error 0.16
|
Adverse Events
120-160mg Ziprasidone
40-80 mg Ziprasidone
Placebo
Serious adverse events
| Measure |
120-160mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
Subjects were assigned to placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
|
General disorders
Oedema peripheral
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
|
Infections and infestations
Pneumonia
|
0.00%
0/171
|
0.61%
1/165
|
0.00%
0/168
|
|
Infections and infestations
Upper respiratory tract infection
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
|
Infections and infestations
Urinary tract infection
|
0.58%
1/171
|
0.61%
1/165
|
0.00%
0/168
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/171
|
0.61%
1/165
|
0.00%
0/168
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/171
|
0.61%
1/165
|
0.00%
0/168
|
|
Psychiatric disorders
Bipolar I disorder
|
0.58%
1/171
|
0.00%
0/165
|
0.60%
1/168
|
|
Psychiatric disorders
Depression
|
0.00%
0/171
|
0.61%
1/165
|
0.60%
1/168
|
|
Psychiatric disorders
Depression suicidal
|
0.58%
1/171
|
0.00%
0/165
|
0.60%
1/168
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/171
|
0.61%
1/165
|
0.00%
0/168
|
|
Psychiatric disorders
Mania
|
0.00%
0/171
|
0.00%
0/165
|
0.60%
1/168
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/171
|
0.00%
0/165
|
0.60%
1/168
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/171
|
0.61%
1/165
|
0.60%
1/168
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
|
Vascular disorders
Hypertension
|
0.58%
1/171
|
0.00%
0/165
|
0.00%
0/168
|
Other adverse events
| Measure |
120-160mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
|
40-80 mg Ziprasidone
Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
|
Placebo
Subjects were assigned to placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/171
|
4.8%
8/165
|
8.3%
14/168
|
|
Gastrointestinal disorders
Dry mouth
|
7.6%
13/171
|
3.6%
6/165
|
3.0%
5/168
|
|
Gastrointestinal disorders
Nausea
|
9.9%
17/171
|
6.1%
10/165
|
6.5%
11/168
|
|
Nervous system disorders
Dizziness
|
7.0%
12/171
|
3.6%
6/165
|
4.2%
7/168
|
|
Nervous system disorders
Headache
|
9.4%
16/171
|
10.9%
18/165
|
7.7%
13/168
|
|
Nervous system disorders
Sedation
|
11.7%
20/171
|
4.8%
8/165
|
1.2%
2/168
|
|
Nervous system disorders
Somnolence
|
17.5%
30/171
|
15.2%
25/165
|
4.8%
8/168
|
|
Psychiatric disorders
Anxiety
|
5.3%
9/171
|
1.8%
3/165
|
3.0%
5/168
|
|
Psychiatric disorders
Insomnia
|
9.4%
16/171
|
5.5%
9/165
|
4.8%
8/168
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER