Trial Outcomes & Findings for Aripiprazole for Bipolar Disorder and Alcohol Use Disorder (NCT NCT02918370)
NCT ID: NCT02918370
Last Updated: 2024-09-19
Results Overview
The Timeline Followback (TLFB) is used to assess recent alcohol use (and if present, other substance use). The calculation is based on the change between baseline and week 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Aripiprazole
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Aripiprazole: Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.
|
Placebo
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Placebo: Inactive ingredient matching the active comparators in appearance.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
39
|
|
Overall Study
COMPLETED
|
34
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Aripiprazole
n=36 Participants
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Aripiprazole: Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.
|
Placebo
n=39 Participants
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Placebo: Inactive ingredient matching the active comparators in appearance.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.71 years
STANDARD_DEVIATION 9.35 • n=5 Participants
|
43.58 years
STANDARD_DEVIATION 12.25 • n=7 Participants
|
43.65 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
TLFB (Drinks per Drinking Day)
|
8.42 standard drinks per drinking day
STANDARD_DEVIATION 5.12 • n=5 Participants
|
10.02 standard drinks per drinking day
STANDARD_DEVIATION 7.94 • n=7 Participants
|
9.25 standard drinks per drinking day
STANDARD_DEVIATION 6.74 • n=5 Participants
|
|
HRSD
|
13.62 units on a scale
STANDARD_DEVIATION 7.40 • n=5 Participants
|
14.19 units on a scale
STANDARD_DEVIATION 7.56 • n=7 Participants
|
13.82 units on a scale
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
IDS-SR
|
26.03 units on a scale
STANDARD_DEVIATION 15.79 • n=5 Participants
|
30.62 units on a scale
STANDARD_DEVIATION 15.42 • n=7 Participants
|
28.42 units on a scale
STANDARD_DEVIATION 15.66 • n=5 Participants
|
|
YMRS
|
8.92 units on a scale
STANDARD_DEVIATION 6.80 • n=5 Participants
|
10.33 units on a scale
STANDARD_DEVIATION 6.96 • n=7 Participants
|
9.85 units on a scale
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
CIWA-Ar
|
2.50 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
3.05 units on a scale
STANDARD_DEVIATION 3.60 • n=7 Participants
|
2.79 units on a scale
STANDARD_DEVIATION 3.18 • n=5 Participants
|
|
PACS
|
19.50 units on a scale
STANDARD_DEVIATION 6.31 • n=5 Participants
|
17.79 units on a scale
STANDARD_DEVIATION 7.53 • n=7 Participants
|
18.60 units on a scale
STANDARD_DEVIATION 6.98 • n=5 Participants
|
|
BIS-11
|
79.09 units on a scale
STANDARD_DEVIATION 13.41 • n=5 Participants
|
78.10 units on a scale
STANDARD_DEVIATION 13.34 • n=7 Participants
|
78.56 units on a scale
STANDARD_DEVIATION 13.29 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe Timeline Followback (TLFB) is used to assess recent alcohol use (and if present, other substance use). The calculation is based on the change between baseline and week 12.
Outcome measures
| Measure |
Aripiprazole
n=36 Participants
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Aripiprazole: Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.
|
Placebo
n=39 Participants
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
Placebo: Inactive ingredient matching the active comparators in appearance.
|
|---|---|---|
|
Timeline Follow Back (TLFB)
|
-0.82 drinks per drinking day
Standard Deviation 5.86
|
-0.71 drinks per drinking day
Standard Deviation 4.23
|
Adverse Events
Aripiprazole
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aripiprazole
n=36 participants at risk
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
|
Placebo
n=39 participants at risk
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
|
|---|---|---|
|
Metabolism and nutrition disorders
increased glucose
|
0.00%
0/36 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Nervous system disorders
Flare up of multiple sclerosis
|
0.00%
0/36 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
Other adverse events
| Measure |
Aripiprazole
n=36 participants at risk
Aripiprazole will be given to the participant beginning at 2 mg per day(QD) then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
|
Placebo
n=39 participants at risk
Matching placebo will be given to the participant beginning at 2mg QD then titrating up to 5 mg QD at week 1, 10 mg QD at week 2, 15 mg QD at week 3 until the end of the preliminary phase. If the participant qualifies for the extension phase, then they will be titrated up again at week 12 to 30 mg QD.
|
|---|---|---|
|
General disorders
Restlessness/Fidgeting
|
30.6%
11/36 • 12 weeks
|
5.1%
2/39 • 12 weeks
|
|
Renal and urinary disorders
Increased urinary frequency or difficulty
|
5.6%
2/36 • 12 weeks
|
7.7%
3/39 • 12 weeks
|
|
General disorders
Dry mouth
|
16.7%
6/36 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Nervous system disorders
Headache
|
8.3%
3/36 • 12 weeks
|
7.7%
3/39 • 12 weeks
|
|
Gastrointestinal disorders
Nausea or vomiting
|
36.1%
13/36 • 12 weeks
|
10.3%
4/39 • 12 weeks
|
|
General disorders
erectile dysfunction or decreased libido
|
0.00%
0/36 • 12 weeks
|
7.7%
3/39 • 12 weeks
|
|
General disorders
increased appetite or weight gain
|
11.1%
4/36 • 12 weeks
|
12.8%
5/39 • 12 weeks
|
|
General disorders
Somnolence
|
25.0%
9/36 • 12 weeks
|
5.1%
2/39 • 12 weeks
|
|
General disorders
Insomnia
|
5.6%
2/36 • 12 weeks
|
7.7%
3/39 • 12 weeks
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/36 • 12 weeks
|
5.1%
2/39 • 12 weeks
|
|
General disorders
fatigue
|
5.6%
2/36 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Gastrointestinal disorders
dyspepsia
|
11.1%
4/36 • 12 weeks
|
0.00%
0/39 • 12 weeks
|
|
Gastrointestinal disorders
constipation
|
8.3%
3/36 • 12 weeks
|
2.6%
1/39 • 12 weeks
|
|
Nervous system disorders
tremors
|
2.8%
1/36 • 12 weeks
|
5.1%
2/39 • 12 weeks
|
|
Nervous system disorders
dizziness or lightheadedness
|
2.8%
1/36 • 12 weeks
|
7.7%
3/39 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place