Trial Outcomes & Findings for Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder (NCT NCT00572117)

NCT ID: NCT00572117

Last Updated: 2017-01-09

Results Overview

Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2017-01-09

Participant Flow

Participant milestones

Measure	Topiramate Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.	Placebo (Inert Pill) Arm Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
Overall Study STARTED	5	7
Overall Study COMPLETED	3	5
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder

Baseline characteristics by cohort

Measure	Topiramate n=5 Participants Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.	Placebo (Inert Pill) Arm n=7 Participants Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.	Total n=12 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	46.6 years STANDARD_DEVIATION 8.3 • n=7 Participants	43.6 years STANDARD_DEVIATION 9.7 • n=5 Participants
Gender Female	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Average number of drinks/heavy drinking days/week as measured using the Timeline Follow Back (TLFB) scale. A heavy drinking day is defined as a 5 or more standard drinks in a single day for males, 4 or more standard drinks in a single day for females. Drinks are standardized across types of alcohol to estimate the amount of alcohol consumes. For example, a 12 oz. beer of 4-5% alcohol by volume is considered one drink.

Outcome measures

Measure	Topiramate n=5 Participants Change in average number of drinks/heavy drinking day	Placebo (Inert Pill) Arm n=7 Participants Change in average number of drinks/heavy drinking day
Amount of Alcohol Consumed	-1.38 number of drinks per heavy drinking day Interval -4.93 to 2.17	-0.69 number of drinks per heavy drinking day Interval -1.68 to 0.31

SECONDARY outcome

Timeframe: Baseline and 12 weeks

The 17-item Hamilton Depression Rating Scale (HAM-D) is a standard measure of symptoms of depression with a scoring range of 0-53 points. Higher HAM-D scores represent more depression, so a lowering of HAM-D scores is considered a good outcome, an increase in HAM-D scores considered a worsening of outcomes.

Outcome measures

Measure	Topiramate n=5 Participants Change in average number of drinks/heavy drinking day	Placebo (Inert Pill) Arm n=7 Participants Change in average number of drinks/heavy drinking day
Effect of Treatment on Mood Symptoms	-2.00 units on a scale Interval -6.21 to 2.21	-0.72 units on a scale Interval -8.96 to 7.54

Adverse Events

Topiramate

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo (Inert Pill) Arm

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Topiramate n=5 participants at risk Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.	Placebo (Inert Pill) Arm n=7 participants at risk Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
Psychiatric disorders Hospitalization	0.00% 0/5	14.3% 1/7 • Number of events 1

Other adverse events

Measure	Topiramate n=5 participants at risk Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.	Placebo (Inert Pill) Arm n=7 participants at risk Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks. Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.
Nervous system disorders Paresthesia	20.0% 1/5 • Number of events 1	14.3% 1/7 • Number of events 1

Additional Information

Michael J. Ostacher, MD, MPH, MMSc

Stanford University School of Medicine

Phone: 650-493-5000

Email: ostacher@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place