Trial Outcomes & Findings for A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression. (NCT NCT00282464)
NCT ID: NCT00282464
Last Updated: 2021-03-29
Results Overview
Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.
COMPLETED
PHASE3
392 participants
Baseline to Week 6
2021-03-29
Participant Flow
7 day washout: psychotropic drugs and lithium. 4 week washout: monoamine oxidase inhibitors. Depot neuroleptic DC'd 6 months before study entry.11 subjects assigned to but not treated with drug: 9 lost to follow up, 1 no longer willing to participate, 1 DC'd due to protocol violation
Participant milestones
| Measure |
Ziprasidone 20-80mg Bid
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
196
|
|
Overall Study
COMPLETED
|
112
|
134
|
|
Overall Study
NOT COMPLETED
|
73
|
62
|
Reasons for withdrawal
| Measure |
Ziprasidone 20-80mg Bid
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
26
|
20
|
|
Overall Study
Lack of Efficacy
|
8
|
8
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
|
Overall Study
Withdrawal by Subject
|
24
|
10
|
|
Overall Study
laboratory abnormality
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
7
|
|
Overall Study
Patient moved
|
1
|
0
|
|
Overall Study
patient non-compliant
|
3
|
0
|
|
Overall Study
patient no show
|
0
|
1
|
|
Overall Study
patient incarcerated
|
0
|
1
|
|
Overall Study
family crisis
|
0
|
1
|
|
Overall Study
dispensed wrong kit
|
0
|
1
|
|
Overall Study
dropped due to missed visits
|
0
|
1
|
Baseline Characteristics
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.
Baseline characteristics by cohort
| Measure |
Ziprasidone 20-80mg Bid
n=185 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=196 Participants
|
Total
n=381 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.4 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
40.0 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 6Population: Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases. Overall is Average of Weeks 1 - 6.
Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 1 (n= 177, 189)
|
-7.23 score on scale
Standard Error 0.79
|
-5.02 score on scale
Standard Error 0.71
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 2 (n=160, 176)
|
-9.99 score on scale
Standard Error 0.79
|
-8.13 score on scale
Standard Error 0.72
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 3 (n=149, 163)
|
-11.88 score on scale
Standard Error 0.83
|
-10.04 score on scale
Standard Error 0.83
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Overall (n= 180, 190)
|
-11.97 score on scale
Standard Error 0.77
|
-10.09 score on scale
Standard Error 0.70
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 4 (n=135, 153)
|
-13.29 score on scale
Standard Error 0.92
|
-11.53 score on scale
Standard Error 0.85
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 5 (n=121, 146)
|
-14.53 score on scale
Standard Error 0.95
|
-12.55 score on scale
Standard Error 0.88
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Week 6 (n=116, 141)
|
-14.88 score on scale
Standard Error 1.02
|
-13.24 score on scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases Not all subjects responded at each week. Endpoint is ITT population Last Observation Carried Forward (LOCF)
Participants with MADRS Total Score greater than or equal to 50 percent decrease from baseline responded yes; others responded no. MADRS: 10-item instrument measuring depression; scale 0(Normal) \& 6 (most abnormal)for each item. Total possible score is 0 - 60. Endpoint is last observation carried forward (LOCF)
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 1: Yes
|
40 participants
|
24 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 1: No
|
137 participants
|
168 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 2: Yes
|
55 participants
|
48 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 2: No
|
105 participants
|
128 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 3: Yes
|
71 participants
|
60 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 3: No
|
78 participants
|
105 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 4: Yes
|
76 participants
|
66 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 4: No
|
59 participants
|
87 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 5: Yes
|
81 participants
|
77 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 5: No
|
40 participants
|
69 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 6: Yes
|
76 participants
|
83 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Week 6: No
|
40 participants
|
58 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Endpoint: Yes
|
95 participants
|
97 participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Montgomery-Asberg Rating Scale (MADRS) Total Score
Endpoint: No
|
85 participants
|
93 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 3, Week 6Population: Weeks 3, 6 are Intent to treat (ITT) population Observed Cases. Not all subjects responded at each week. Endpoint is ITT population Last Observation Carried Forward (LOCF)
Participants with greater than or equal to 50 percent decrease from baseline in HAM-D 17 total score responded yes; others responded no. Total score is first 17 items of the HAM-D 25: measures range of depressive symptoms. Scale: 8 items 0-2 \& 9 items 0-4, higher scores being more severe. Total possible score is 0 - 52. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 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
|
41 Participants
|
59 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Endpoint: Yes
|
95 Participants
|
97 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Endpoint: No
|
73 Participants
|
84 Participants
|
|
Response Greater Than or Equal to 50 Percent Decrease From Baseline in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 3: Yes
|
72 Participants
|
65 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
|
95 Participants
|
112 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
|
85 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: Week 1 to Week 6Population: Weeks 1 - 6 are Intent to treat (ITT) population Observed Cases. Not all subjects responded at each week. Endpoint is ITT population Last Observation Carried Forward (LOCF)
Remission response is yes if MADRS total score less than or equal to 12; if not, response is no. MADRS: 10-item instrument measuring depression; scale 0(Normal) \& 6(most abnormal).Total possible score is 0 - 60. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 1: Yes
|
41 Participants
|
21 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 1: No
|
136 Participants
|
168 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 2: Yes
|
54 Participants
|
41 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 2: No
|
106 Participants
|
135 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 3: Yes
|
70 Participants
|
58 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 3: No
|
79 Participants
|
105 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 4: Yes
|
66 Participants
|
60 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 4: No
|
69 Participants
|
93 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 5: Yes
|
70 Participants
|
66 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 5: No
|
51 Participants
|
80 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 6: Yes
|
70 Participants
|
72 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Week 6: No
|
46 Participants
|
69 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Endpoint: Yes
|
87 Participants
|
81 Participants
|
|
Remission as Measured by Montgomery Asberg Depression Scale (MADRS) Total Score Less Than or Equal to 12
Endpoint: No
|
93 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: Week 3, Week 6Population: Weeks 3, 6 are Intent to treat (ITT) population Observed Cases. Not all subjects responded at each week. Endpoint is ITT population Last Observation Carried Forward (LOCF)
Remission response is yes when HAM-D 17 total score is less than or equal to 7; if not, response is no. Total score is first 17 items of HAM-D 25, measures range of depressive symptoms. Scale: 8 items 0-2 and 9 items 0-4, higher scores more severe. Total possible score is 0 - 52. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Endpoint: Yes
|
59 Participants
|
55 Participants
|
|
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Endpoint: No
|
109 Participants
|
126 Participants
|
|
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Week 3: Yes
|
32 Participants
|
33 Participants
|
|
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Week 3: No
|
135 Participants
|
144 Participants
|
|
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Week 6: Yes
|
56 Participants
|
51 Participants
|
|
Remission as Measured by Hamilton Asberg Depression Rating Scale (HAM-D 17) Total Score Less Than or Equal to 7
Week 6: No
|
70 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF).
Change is observed value at each visit minus baseline value. HAM-D 17 Total score is first 17 items of HAM-D 25; measures range of depressive symptoms patient currently experiencing. Scale: 8 items 0-2 \& 9 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 52.Endpoint is LOCF
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 3 (n=167, 177)
|
-9.91 score on scale
Standard Error 0.88
|
-8.73 score on scale
Standard Error 0.84
|
|
Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Week 6 (n=126, 150)
|
-12.91 score on scale
Standard Error 1.15
|
-12.07 score on scale
Standard Error 1.06
|
|
Change in Hamilton Depression Rating Scale (HAM-D 17) Total Score
Endpoint (n=168, 181)
|
-6.92 score on scale
Standard Error 1.36
|
-7.11 score on scale
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to Treat (ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF).
Change is observed value at each visit minus baseline value. HAM-D: 25-item instrument measuring the range of depressive symptoms patient currently experiencing. Scale: 14 items 0-2 \& 11 items 0-4; 0=absent or not depressed, 2 or 4=most severe or extreme. Total possible score is 0 - 72. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
Week 3 (n=167, 177)
|
-11.68 score on scale
Standard Error 1.07
|
-10.76 score on scale
Standard Error 1.02
|
|
Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
Week 6 (n=126, 150)
|
-15.48 score on scale
Standard Error 1.32
|
-14.80 score on scale
Standard Error 1.22
|
|
Change in Total Score in Hamiliton Depression Rating Scale (HAM-D 25)
Endpoint (n=168, 181)
|
-8.06 score on scale
Standard Error 1.64
|
-8.58 score on scale
Standard Error 1.56
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to Treat(ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF).
Change is observed value at each visit minus baseline value. Bech Melancholia is sum of scores on 6 Items pertaining to melancholia within HAM-D. Scale range 0 to 4; higher scores, greater severity. Total possible score is 0 - 24. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Bech Melancholia Score
Week 3 (n =167, 177)
|
-5.22 score on scale
Standard Error 0.50
|
-4.28 score on scale
Standard Error 0.48
|
|
Change in Bech Melancholia Score
Week 6 (n =126, 150)
|
-6.82 score on scale
Standard Error 0.65
|
-6.20 score on scale
Standard Error 0.6
|
|
Change in Bech Melancholia Score
Endpoint (n =168, 181)
|
-3.73 score on scale
Standard Error 0.75
|
-3.61 score on scale
Standard Error 0.71
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to treat (ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF).
Change is observed value at each visit minus baseline value. This test is sum of Scores on 6 Items pertaining to anxiety/somatization within HAM-D. Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 24. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Anxiety/Somatizations Factor Total Score
Week 3 (n =167, 177)
|
-2.84 score on scale
Standard Error 0.31
|
-2.61 score on scale
Standard Error 0.30
|
|
Change in Anxiety/Somatizations Factor Total Score
Week 6 (n =126, 150)
|
-4.09 score on scale
Standard Error 0.37
|
-3.96 score on scale
Standard Error 0.35
|
|
Change in Anxiety/Somatizations Factor Total Score
Endpoint (n =168, 181)
|
-2.18 score on scale
Standard Error 0.43
|
-2.57 score on scale
Standard Error 0.41
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to treat (ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF).
Change is observed value at each visit minus baseline value. Retardation Factor is the sum of scores of 4 items which pertain to retardation within HAM-D. Scores 0 to 4, higher scores reflecting greater severity.Total possible score is 0 - 16. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Retardation Factor Scores
Week 3 (n =167, 177)
|
-3.22 score on scale
Standard Error 0.35
|
-2.68 score on scale
Standard Error 0.34
|
|
Change in Retardation Factor Scores
Week 6 (n =126, 150)
|
-4.38 score on scale
Standard Error 0.45
|
-3.66 score on scale
Standard Error 0.42
|
|
Change in Retardation Factor Scores
Endpoint (n =168, 181)
|
-2.24 score on scale
Standard Error 0.50
|
-1.88 score on scale
Standard Error 0.48
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to treat (ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF)
Change is observed value at each visit minus baseline value. Sleep Disturbance is the sum of scores of 3 items which pertain to sleep disturbance within Hamilton Depression Rating Scale (HAM-D). Scale range 0 to 4 with higher scores reflecting greater severity. Total possible score is 0 - 12.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Sleep Disturbance Factor Score
Week 3 (n =167, 177)
|
-1.51 score on scale
Standard Error 0.24
|
-1.48 score on scale
Standard Error 0.23
|
|
Change in Sleep Disturbance Factor Score
Week 6 (n =126, 150)
|
-2.38 score on scale
Standard Error 0.28
|
-2.31 score on scale
Standard Error 0.26
|
|
Change in Sleep Disturbance Factor Score
Endpoint (n=168, 181)
|
-1.19 score on scale
Standard Error 0.30
|
-1.26 score on scale
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline to Weeks 3, 6Population: Weeks 3, 6 are Intent to treat (ITT) population Observed Cases. Endpoint is ITT population Last Observation Carried Forward (LOCF).
Change is observed value at each visit minus baseline value. HAM-A:14-item scale to rate the intensity of psychic anxiety (items 1- 6, 14) and somatic anxiety (items 7-13) on a 5-point severity scale (0=not present to 4=very severe). Total possible score is 0 - 56.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Hamilton Anxiety Rating (HAM-A)
Week 3 (n=167, 177)
|
-4.63 score on scale
Standard Error 0.69
|
-4.18 score on scale
Standard Error 0.66
|
|
Change in Hamilton Anxiety Rating (HAM-A)
Week 6 (n=126, 150)
|
-6.84 score on scale
Standard Error 0.91
|
-6.64 score on scale
Standard Error 0.84
|
|
Change in Hamilton Anxiety Rating (HAM-A)
Endpoint (n=168, 181)
|
-3.05 score on scale
Standard Error 1.06
|
-3.26 score on scale
Standard Error 1.01
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases. Overall is Average of Weeks 1 - 6.
Change is observed value at each visit minus baseline value. YMRS: 11 item instrument with scale range 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. Overall is average response Week 1 - 6.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 1 (n=177, 189)
|
0.40 score on scale
Standard Error 0.36
|
0.69 score on scale
Standard Error 0.33
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 2 (n=160, 176)
|
0.49 score on scale
Standard Error 0.39
|
-0.13 score on scale
Standard Error 0.31
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 3 (n=149, 163)
|
-0.13 score on scale
Standard Error 0.41
|
0.00 score on scale
Standard Error 0.34
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 4 (n=135, 153)
|
-0.60 score on scale
Standard Error 0.36
|
-0.77 score on scale
Standard Error 0.31
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 5 (n=121, 146)
|
-0.94 score on scale
Standard Error 0.35
|
-0.77 score on scale
Standard Error 0.31
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Week 6 (n=116, 141)
|
-0.45 score on scale
Standard Error 0.43
|
-0.66 score on scale
Standard Error 0.37
|
|
Change in Total Score of Young Mania Rating Scale (YMRS)
Overall (n=180, 190)
|
-0.20 score on scale
Standard Error 0.32
|
-0.27 score on scale
Standard Error 0.26
|
SECONDARY outcome
Timeframe: Baseline to week 6Population: Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases. Overall is Average of Weeks 1 - 6.
Change is observed value at each visit minus baseline value. CGI-S is an instrument to measure severity of mental illness. Scale range: 0 = not assessed, 1 = normal, 7 = among most extremely ill
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Week 1 (n=177, 188)
|
-0.39 score on scale
Standard Error 0.08
|
-0.25 score on scale
Standard Error 0.07
|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Week 2 (n=160, 176)
|
-0.66 score on scale
Standard Error 0.08
|
-0.51 score on scale
Standard Error 0.08
|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Week 3 (n=149, 163)
|
-0.88 score on scale
Standard Error 0.10
|
-0.84 score on scale
Standard Error 0.09
|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Week 4 (n=135, 152)
|
-1.03 score on scale
Standard Error 0.11
|
-0.98 score on scale
Standard Error 0.10
|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Week 5 (n=121, 146)
|
-1.27 score on scale
Standard Error 0.11
|
-1.15 score on scale
Standard Error 0.10
|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Week 6 (n=116, 140)
|
-1.34 score on scale
Standard Error 0.11
|
-1.28 score on scale
Standard Error 0.11
|
|
Change in Global Clinical Severity of Symptoms (CGI-S)
Overall (n=180, 190)
|
-0.93 score on scale
Standard Error 0.08
|
-0.84 score on scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline to Week 6Population: Week 1 - Week 6 is Intent to treat (ITT) population Observed Cases. Overall is Average of Weeks 1 - 6.
Change is observed value at each visit minus baseline value. 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 |
Ziprasidone 20-80mg Bid
n=180 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=190 Participants
|
|---|---|---|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 1 (n=177, 188)
|
3.37 score on scale
Standard Error 0.10
|
3.61 score on scale
Standard Error 0.10
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 2 (n=160, 176)
|
3.09 score on scale
Standard Error 0.11
|
3.29 score on scale
Standard Error 0.11
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 3 (n=149, 163)
|
2.89 score on scale
Standard Error 0.12
|
3.04 score on scale
Standard Error 0.11
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 4 (n=135, 152)
|
2.74 score on scale
Standard Error 0.12
|
2.94 score on scale
Standard Error 0.11
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 5 (n=121, 146)
|
2.61 score on scale
Standard Error 0.13
|
2.84 score on scale
Standard Error 0.12
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Week 6 (n=116, 140)
|
2.52 score on scale
Standard Error 0.13
|
2.64 score on scale
Standard Error 0.12
|
|
Change in Global Clinical Improvement of Symptoms (CGI -I)
Overall (n=180, 190)
|
2.87 score on scale
Standard Error 0.10
|
3.06 score on scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline to week 6 (Endpoint)Population: Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 154, 169; N = 180, 190
Change is observed value at each visit minus baseline value. GAF is an instrument used to assess global psychological, social, \& occupational functioning. Scale range: 100 = normal and 0 = greatest abnormality.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=154 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=169 Participants
|
|---|---|---|
|
Change in Global Assessment of Functioning (GAF)
|
9.59 score on scale
Standard Error 1.52
|
9.53 score on scale
Standard Error 1.42
|
SECONDARY outcome
Timeframe: Baseline to week 6 (endpoint)Population: Change from baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 153, 168; N = 180, 190
Change is observed value at each visit minus baseline value. Q-LES-Q: 16- item instrument for a patient's assessment of his/her quality of life. Scale range: overall level of satisfaction 1=very poor to 5=Very good. 1 item (medication)can be left blank. Total possible score 15 - 80.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=153 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=168 Participants
|
|---|---|---|
|
Change in Quality of Life, Enjoyment, and Satisfaction Scale (Q-LES-Q) Total Score
|
0.06 score on scale
Standard Error 0.02
|
0.06 score on scale
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline to week 6 (endpoint)Population: Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 149, 162; N = 180, 190
Change is observed value at each visit minus baseline value. SDS is a patient rated measure of disability and impairment in work/school, social life, family life/home responsibilities. Scale range: 0-10 with 0=no disruption,10=extreme disruption. Total possible score is 0 - 30.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=149 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=162 Participants
|
|---|---|---|
|
Change in Sheehan Disability Scale (SDS) Total Score
|
-3.69 score on scale
Standard Error 0.93
|
-3.05 score on scale
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Baseline to week 6 (endpoint)Population: Baseline to Endpoint. Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 141, 164; N = 180, 190
Change is observed value at each visit minus baseline value. BPCoRs: Subject interview with 20-items measuring cognitive deficits \& degree of affect on functioning. Scale range:0 to 4, higher numbers, greater impairment. Total possible score is 0 - 80. Endpoint=last observation carried forward (LOCF)
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=141 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=164 Participants
|
|---|---|---|
|
Change in Bipolar Cognition Rating Scale (BPCoRS) Interviewer Global Rating of Subject
|
-0.65 score on scale
Standard Error 0.24
|
-0.73 score on scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline to week 6 (endpoint)Population: Baseline to Endpoint. Endpoint is ITT population Last Observation Carried Forward (LOCF). n = 97, 104; N = 180, 190
Change is observed value at each visit minus baseline value. Informant Global Rating is interview with informant of subject using BPCoRS, a 20-item instrument measuring cognitive deficits \& degree of affect on functioning. Scale: 0 to 4, higher numbers = greater impairment. Total possible score is 0 - 80. Endpoint is LOCF.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=97 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=104 Participants
|
|---|---|---|
|
Change in Bipolar Cognition Rating Scale (BPCoRS) Informant Global Rating
|
4.66 score on scale
Standard Error 0.21
|
4.68 score on scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline to week 6 (endpoint)Population: Endpoint is Intent to Treat (ITT) population Last Observation Carried Forward (LOCF). n = 137, 158; N = 180, 190
Change in Rating by interviewer, using BPCoRS, 20-item instrument measuring cognitive deficits and the degree of affect on functioning; 4 point scale with higher numbers reflecting greater impairment.Total possible score is 0 - 80.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=137 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=158 Participants
|
|---|---|---|
|
Change in Bipolar Cognition Rating Scale (BPCoRS) Global Rating by Interviewer
|
4.72 score on scale
Standard Error 0.18
|
4.63 score on scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline to Week 6 (endpoint)Population: Endpoint is Intent to Treat (ITT) Last Observation Carried Forward (LOCF). n = 140, 162; N = 180, 190
Change is observed value at each visit minus baseline value. Subject Rating: Subject's perceived change in status using a 20-item instrument measuring cognitive deficits and degree of affect on funtioning. Scale 0 to 4, higher numbers reflecting greater impairment. Total possible score is 0 - 80. Endpoint is last observation carried forward.
Outcome measures
| Measure |
Ziprasidone 20-80mg Bid
n=140 Participants
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
n=162 Participants
|
|---|---|---|
|
Change in Bipolar Cognition Rating Scale (BPCoRS) Subject Rating at Endpoint
|
4.69 score on scale
Standard Error 0.19
|
4.81 score on scale
Standard Error 0.17
|
Adverse Events
Ziprasidone 20-80mg Bid
Placebo
Serious adverse events
| Measure |
Ziprasidone 20-80mg Bid
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/185
|
0.51%
1/196
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/185
|
0.51%
1/196
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/185
|
0.51%
1/196
|
|
Psychiatric disorders
Suicidal ideation
|
1.1%
2/185
|
0.51%
1/196
|
|
Psychiatric disorders
Suicide attempt
|
0.54%
1/185
|
0.00%
0/196
|
Other adverse events
| Measure |
Ziprasidone 20-80mg Bid
For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
|
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
8/185
|
7.7%
15/196
|
|
Gastrointestinal disorders
Nausea
|
5.9%
11/185
|
10.7%
21/196
|
|
General disorders
Fatigue
|
7.0%
13/185
|
4.1%
8/196
|
|
Nervous system disorders
Dizziness
|
6.5%
12/185
|
5.1%
10/196
|
|
Nervous system disorders
Headache
|
11.4%
21/185
|
10.7%
21/196
|
|
Nervous system disorders
Sedation
|
11.9%
22/185
|
3.1%
6/196
|
|
Nervous system disorders
Somnolence
|
13.5%
25/185
|
2.6%
5/196
|
|
Psychiatric disorders
Depression
|
3.2%
6/185
|
6.6%
13/196
|
|
Psychiatric disorders
Insomnia
|
4.9%
9/185
|
5.1%
10/196
|
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