Trial Outcomes & Findings for Cognitive Enhancement in Bipolar Disorder (NCT NCT00597896)
NCT ID: NCT00597896
Last Updated: 2015-06-12
Results Overview
The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
COMPLETED
PHASE4
50 participants
Change from Baseline to Week 8
2015-06-12
Participant Flow
Participant milestones
| Measure |
Active Pramipexole
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
21
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cognitive Enhancement in Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID - pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.81 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
44.42 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
44.14 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
24 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The examinee is read a sequence of numbers and must recall the numbers in the same order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)
Baseline
|
8.43 number of correct numbers recalled
Standard Deviation 2.93
|
8.54 number of correct numbers recalled
Standard Deviation 3.02
|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)
Week 8
|
8.48 number of correct numbers recalled
Standard Deviation 2.40
|
8.13 number of correct numbers recalled
Standard Deviation 2.52
|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)
Change from Baseline to Week 8
|
.05 number of correct numbers recalled
Standard Deviation 1.72
|
-.41 number of correct numbers recalled
Standard Deviation 2.08
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The examinee is read a sequence of numbers and must recall the numbers in reverse order. Measures auditory attention and verbal working memory. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)
Baseline
|
6.48 number of correct numbers recalled
Standard Deviation 2.09
|
6.46 number of correct numbers recalled
Standard Deviation 2.48
|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)
Week 8
|
6.86 number of correct numbers recalled
Standard Deviation 1.96
|
6.67 number of correct numbers recalled
Standard Deviation 3.09
|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)
Change from Baseline to Week 8
|
.38 number of correct numbers recalled
Standard Deviation 2.33
|
.21 number of correct numbers recalled
Standard Deviation 1.35
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
Using a key, the examinee copies symbols that are paired with numbers within a specified time limit. Measures visual scanning and graphomotor speed. The standard scores were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test
Baseline
|
8.52 units on a scale
Standard Deviation 2.64
|
8.08 units on a scale
Standard Deviation 2.83
|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test
Week 8
|
9.05 units on a scale
Standard Deviation 3.46
|
8.75 units on a scale
Standard Deviation 3.07
|
|
Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test
Change from Baseline to Week 8
|
.52 units on a scale
Standard Deviation 2.23
|
.67 units on a scale
Standard Deviation 1.86
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The Stroop Color-Word Test consists of a word page with words printed in black ink, a color page with 'Xs' printed in color, and a color-word page where the color and the word do not match. The examinee reads the words or names the ink colors as quickly as possible within a time limit. Measures selective attention and inhibitory control. The raw scores (total number of words read) for each trial were reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Word-Week 8
|
103.10 words
Standard Deviation 16.09
|
94.33 words
Standard Deviation 14.40
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Word- Change from Baseline to Week 8
|
3.14 words
Standard Deviation 12.46
|
-1.08 words
Standard Deviation 10.08
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Color- Baseline
|
68.10 words
Standard Deviation 16.75
|
66.54 words
Standard Deviation 12.56
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Color-Week 8
|
72.24 words
Standard Deviation 15.36
|
66.29 words
Standard Deviation 12.87
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Color-Word- Baseline
|
41.57 words
Standard Deviation 9.93
|
39.29 words
Standard Deviation 9.43
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Color-Word-Week 8
|
43.95 words
Standard Deviation 12.55
|
40.08 words
Standard Deviation 10.14
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Color-Word-Change from Baseline to Week 8
|
2.38 words
Standard Deviation 8.96
|
.79 words
Standard Deviation 6.32
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Word-Baseline
|
99.95 words
Standard Deviation 18.20
|
95.42 words
Standard Deviation 13.16
|
|
Change From Baseline to Week 8 in Stroop Color-Word Test
Color- Change from Baseline to Week 8
|
4.14 words
Standard Deviation 9.08
|
-.25 words
Standard Deviation 8.05
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The examinee is instructed to connect a set of 25 dots as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Trail Making Test Part A
Week 8
|
28.57 seconds
Standard Deviation 12.05
|
32.79 seconds
Standard Deviation 13.99
|
|
Change From Baseline to Week 8 in Trail Making Test Part A
Baseline
|
32.88 seconds
Standard Deviation 15.66
|
35.37 seconds
Standard Deviation 12.36
|
|
Change From Baseline to Week 8 in Trail Making Test Part A
Change from Baseline to Week 8
|
-4.31 seconds
Standard Deviation 8.23
|
-2.58 seconds
Standard Deviation 13.48
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The examinee is instructed to connect a set of 25 dots, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe "executive" functions of visual search, set-switching and conceptual flexibility. The total time in seconds was reported for this measure. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Trail Making Test Part B
Baseline
|
76.90 seconds
Standard Deviation 30.64
|
106.14 seconds
Standard Deviation 75.30
|
|
Change From Baseline to Week 8 in Trail Making Test Part B
Week 8
|
75.55 seconds
Standard Deviation 34.52
|
93.39 seconds
Standard Deviation 73.09
|
|
Change From Baseline to Week 8 in Trail Making Test Part B
Change from Baseline to Week 8
|
-1.35 seconds
Standard Deviation 28.48
|
-12.74 seconds
Standard Deviation 43.76
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The d2 Test of Attention consist of 14 lines, each comprised of 47 characters, for a total of 658 items. The examinee must scan each line and cross out all the "d's" with two dashes. The subject is allowed 20 seconds per line. Measures rapid processing of visual information and motor speed.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in d2 Test of Attention
|
.90 units on a scale
Standard Deviation 6.84
|
1.54 units on a scale
Standard Deviation 7.91
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The examinee is required to recall a list of 12 words over 3 immediate learning trials, a delayed recall trial and a recognition trial. Measures learning and retention of verbal material. The total number of words recalled during the delayed recall trial was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Hopkins Verbal Learning Test
Week 8
|
8.09 words
Standard Deviation 2.86
|
8.42 words
Standard Deviation 2.34
|
|
Change From Baseline to Week 8 in Hopkins Verbal Learning Test
Baseline
|
8.00 words
Standard Deviation 2.17
|
8.13 words
Standard Deviation 2.61
|
|
Change From Baseline to Week 8 in Hopkins Verbal Learning Test
Change from Baseline to Week 8
|
.09 words
Standard Deviation 2.55
|
.29 words
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The examinee is required to say as many words as they can think of in one minute that begin with a given letter of the alphabet. The task contains three trials. Measures phonetic verbal fluency. The raw score (total words recorded across the three trials) was reported. Values indicate the change from baseline to week 8, with positive values reflecting higher scores at week 8 and negative values reflecting lower scores at week 8.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency
Change from Baseline to Week 8
|
1.29 words
Standard Deviation 6.76
|
-.13 words
Standard Deviation 8.74
|
|
Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency
Baseline
|
38.33 words
Standard Deviation 13.48
|
33.63 words
Standard Deviation 12.13
|
|
Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency
Week 8
|
39.62 words
Standard Deviation 14.30
|
33.50 words
Standard Deviation 10.49
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-64.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint
|
-.9 units on a scale
Standard Deviation 5.5
|
-1.5 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 8Population: All randomized participants were assessed per protocol
The CARS-M is a 15-item clinician-rated scale designed to assess severity of both manic and psychotic symptoms. There are 2 subscales: a mania scale and a scale for psychotic symptoms and disorganization. There are a total of 15 items on the CARS-M, each of which is rated on a 6-point Likert scale (0/Absent to 5/Extreme), with the exception of item 15 ("Insight") which is rated on a 5-point Likert scale. These items yield two subscale scores-one for Mania (items 1-10) and one for Psychosis (items 11-15). Higher scores indicate worsening. The responses are summed to yield the CARS-M-15 score that ranges from 0-74.
Outcome measures
| Measure |
Active Pramipexole
n=21 Participants
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 Participants
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint
|
.5 units on a scale
Standard Deviation 4.0
|
-.9 units on a scale
Standard Deviation 3.0
|
Adverse Events
Active Pramipexole
Placebo Pramipexole
Serious adverse events
| Measure |
Active Pramipexole
n=21 participants at risk
0.125 mg BID-0.75 mg BID pramipexole
|
Placebo Pramipexole
n=24 participants at risk
0.125 mg BID-0.75 mg BID - matching placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
4.8%
1/21
|
4.2%
1/24
|
|
General disorders
Car accident
|
4.8%
1/21
|
0.00%
0/24
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place