Trial Outcomes & Findings for Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder (NCT NCT00741598)
NCT ID: NCT00741598
Last Updated: 2017-05-02
Results Overview
CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are: CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16.
COMPLETED
PHASE4
72 participants
Measured at screening and Week 16
2017-05-02
Participant Flow
The study procedures were conducted between January 2009 and June 2015 at two sites: the Mood and Anxiety Disorders Program at Icahn School of Medicine at Mount Sinai and the Bipolar Clinical Research Program at the Massachusetts General Hospital.
Participant milestones
| Measure |
Galantamine-ER
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
placebo equivalent
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
39
|
|
Overall Study
COMPLETED
|
24
|
30
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Galantamine-ER
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
placebo equivalent
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Efficacy and Safety of Galantamine for Improving Dysfunction in People With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Galantamine-ER
n=33 Participants
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=39 Participants
placebo equivalent
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
47.8 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
46.5 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at screening and Week 16CVLT is a test measuring verbal learning and verbal memory. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The outcome measures presented are: CVLT Total Trials 1-5, Baseline = Number of total words remembered, sum of trials 1-5, at baseline CVLT Total Trials 1-5, Week 16 = Number of total words remembered, sum of trials 1-5, at week 16.
Outcome measures
| Measure |
Galantamine-ER
n=24 Participants
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=30 Participants
16-week treatment with flexible doses of placebo equivalent
|
|---|---|---|
|
Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16
CVLT Total Trials 1-5, Baseline
|
50.15 number of total words remembered
Standard Deviation 13.36
|
47.21 number of total words remembered
Standard Deviation 10.77
|
|
Scores on the California Verbal Learning Test (CVLT-II) at Screening and Week 16
CVLT Total Trials 1-5, Week 16
|
58.88 number of total words remembered
Standard Deviation 14.69
|
52.90 number of total words remembered
Standard Deviation 13.17
|
PRIMARY outcome
Timeframe: Measured at screening and Week 16WCST (Wisconsin Card Sorting Test) is a neuropsychological test measuring the ability to display flexibility in the face of changing schedules of reinforcement. Subjects are presented with cards and requested to match them. Unbeknownst to the subject, the matching rules change while the test is delivered. The test measures subjects' ability to understand the new rules. The outcome measures presented are Total correct baseline = total correct card choices at baseline Total errors baseline = total erroneous card choices at baseline Total correct week 16 = total correct card choices at week 16 Total errors baseline = total erroneous card choices at week 16
Outcome measures
| Measure |
Galantamine-ER
n=24 Participants
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=30 Participants
16-week treatment with flexible doses of placebo equivalent
|
|---|---|---|
|
Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
Total Correct Baseline
|
45.87 number of card choices made
Standard Deviation 23.16
|
44.11 number of card choices made
Standard Deviation 19.69
|
|
Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
Total Errors Baseline
|
29.70 number of card choices made
Standard Deviation 19.38
|
29.79 number of card choices made
Standard Deviation 22.54
|
|
Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
Total Correct Week 16
|
51.94 number of card choices made
Standard Deviation 23.79
|
44.28 number of card choices made
Standard Deviation 23.72
|
|
Scores on the Wisconsin Card Sorting Test (WCST) at Screening and Week 16
Total Errors Week 16
|
27.75 number of card choices made
Standard Deviation 18.52
|
29.61 number of card choices made
Standard Deviation 18.52
|
PRIMARY outcome
Timeframe: Measured at screening; baseline; and Weeks 4, 8, 12, and 16Conner's CPT (Conner's Continuous Performance Task) is a neuropsychological test that measures a person's sustained and selective attention. Subjects are instructed to click the space bar when they are presented with any letter except the letter "X". The person must refrain from clicking if they see the letter "X" presented. Clicking to the letter "X" is a commission error, not clicking to other letters are omission errors. The outcome measures presented are Total number of errors = Total number of omission + commission errors This outcome measure is presented at each study visit (baseline, week 4, week 8, week 12, and week 16)
Outcome measures
| Measure |
Galantamine-ER
n=24 Participants
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=30 Participants
16-week treatment with flexible doses of placebo equivalent
|
|---|---|---|
|
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
CPT Total omission + commission errors, Baseline
|
22.16 total number of errors
Standard Deviation 19.78
|
19.40 total number of errors
Standard Deviation 12.38
|
|
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
CPT Total omission + commission errors, Week 4
|
21.87 total number of errors
Standard Deviation 21.10
|
19.24 total number of errors
Standard Deviation 18.08
|
|
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
CPT Total omission + commission errors, Week 8
|
15.61 total number of errors
Standard Deviation 17.67
|
16.39 total number of errors
Standard Deviation 11.15
|
|
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
CPT Total omission + commission errors, Week 12
|
9.91 total number of errors
Standard Deviation 10.11
|
16.41 total number of errors
Standard Deviation 14.70
|
|
The Conners' Continuous Performance Test (CPT) at Baseline, Weeks 4, 8, 12, and 16
CPT Total omission + commission errors, Week 16
|
14.23 total number of errors
Standard Deviation 20.34
|
15.18 total number of errors
Standard Deviation 12.20
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, and 16The LIFE-RIFT is a brief measure of functional impairment. The total scale score is a sum of four items with range of scale from 0 to 26 (from no impairment to severe impairment).
Outcome measures
| Measure |
Galantamine-ER
n=24 Participants
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=30 Participants
16-week treatment with flexible doses of placebo equivalent
|
|---|---|---|
|
The Range of Impaired Functioning Tool (LIFE-RIFT)
LIFE-RIFT total score, Baseline
|
10.39 units on a scale
Standard Deviation 2.52
|
9.41 units on a scale
Standard Deviation 2.89
|
|
The Range of Impaired Functioning Tool (LIFE-RIFT)
LIFE-RIFT total score, Week 4
|
9.66 units on a scale
Standard Deviation 2.79
|
9.03 units on a scale
Standard Deviation 2.42
|
|
The Range of Impaired Functioning Tool (LIFE-RIFT)
LIFE-RIFT total score, Week 8
|
9.07 units on a scale
Standard Deviation 2.80
|
8.53 units on a scale
Standard Deviation 2.36
|
|
The Range of Impaired Functioning Tool (LIFE-RIFT)
LIFE-RIFT total score, Week 12
|
8.24 units on a scale
Standard Deviation 2.35
|
8.03 units on a scale
Standard Deviation 2.80
|
|
The Range of Impaired Functioning Tool (LIFE-RIFT)
LIFE-RIFT total score, Week 16
|
8.88 units on a scale
Standard Deviation 3.19
|
8.20 units on a scale
Standard Deviation 2.91
|
SECONDARY outcome
Timeframe: ScreeningThe Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction. The outcome measures presented are Q-LES-Q Total score = Sum of all scores from all 16 areas of functioning
Outcome measures
| Measure |
Galantamine-ER
n=24 Participants
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=30 Participants
16-week treatment with flexible doses of placebo equivalent
|
|---|---|---|
|
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q Total, Baseline
|
62.3 units on a scale
Standard Deviation 9.79
|
63.03 units on a scale
Standard Deviation 13.18
|
|
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q Total, Week 4
|
66.03 units on a scale
Standard Deviation 15.00
|
64.75 units on a scale
Standard Deviation 15.32
|
|
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q Total, Week 8
|
62.62 units on a scale
Standard Deviation 12.34
|
65.28 units on a scale
Standard Deviation 15.29
|
|
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q Total, Week 12
|
66.96 units on a scale
Standard Deviation 10.32
|
66.52 units on a scale
Standard Deviation 14.89
|
|
Quality of Life Satisfaction Questionnaire (Q-LES-Q)
Q-LES-Q Total, Week 16
|
64.75 units on a scale
Standard Deviation 9.98
|
61.31 units on a scale
Standard Deviation 19.36
|
Adverse Events
Galantamine-ER
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Galantamine-ER
n=33 participants at risk
16-week treatment with flexible doses (8-24mg/day)
|
Placebo
n=39 participants at risk
placebo equivalent
|
|---|---|---|
|
General disorders
Trouble sleeping
|
18.2%
6/33
|
17.9%
7/39
|
|
General disorders
Drowsy
|
15.2%
5/33
|
20.5%
8/39
|
|
General disorders
Nervous/Hyper
|
6.1%
2/33
|
5.1%
2/39
|
|
General disorders
Fatigue
|
9.1%
3/33
|
15.4%
6/39
|
|
General disorders
Irritable
|
9.1%
3/33
|
10.3%
4/39
|
|
General disorders
Headache
|
18.2%
6/33
|
12.8%
5/39
|
|
Gastrointestinal disorders
Nausea/vomiting
|
6.1%
2/33
|
5.1%
2/39
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.1%
3/33
|
5.1%
2/39
|
|
Gastrointestinal disorders
Constipation
|
6.1%
2/33
|
10.3%
4/39
|
Additional Information
Dr. Dan V. Iosifescu
Mood and Anxiety Disorders Program, Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place