Trial Outcomes & Findings for Zonisamide for Heavy Drinkers With Bipolar Disorder (NCT NCT01566370)
NCT ID: NCT01566370
Last Updated: 2017-01-13
Results Overview
The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).
TERMINATED
PHASE2
3 participants
from week 11 through 14 (over 4 weeks)
2017-01-13
Participant Flow
Participant milestones
| Measure |
Zonisamide
Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose
|
Placebo
Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zonisamide for Heavy Drinkers With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Zonisamide
n=2 Participants
Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose
|
Placebo
n=1 Participants
Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo
|
Total
n=3 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
58.5 years
n=5 Participants
|
45 years
n=7 Participants
|
51.75 years
n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gender
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from week 11 through 14 (over 4 weeks)Population: None of the subjects completed the study or made it to the 12 week endpoint.
The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 14 weeksPopulation: None of the subjects completed the study or made it to the 12 week endpoint.
Change from baseline to endpoint in Hamilton scores compared between medication and placebo, using repeated measures
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 14 weeksPopulation: None of the subjects completed the study or made it to the 12 week endpoint.
Comparison between groups on change in scores on the CARS-M over 14 weeks from baseline to endpoint, measured weekly and analyzed with repeated measures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: over four weeks, from week 11 through 14Population: None of the subjects completed the study or made it to the 12 week endpoint.
The difference in total percentage of abstinent compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: from baseline to endpoint, 14 weeksPopulation: None of the subjects completed the study or made it to the 12 week endpoint.
This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeksPopulation: None of the subjects completed the study or made it to the 12 week endpoint.
Difference between groups on change in levels of GGT over time, measured at baseline, week 5, week 9, week 13, and endpoint, using repeated measures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeksPopulation: None of the subjects completed the study or made it to the 12 week endpoint.
Comparison between groups on change in BDI scores over the 14 weeks of the study, measured weekly, using repeated measures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: None of the subjects completed the study or made it to the 12 week endpoint.
The percentage of total drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeks (baseline to endpoint)Population: None of the subjects completed the study or made it to the 12 week endpoint.
A comparison between medication and placebo on the measure of number heavy drinking days per week over the course of the study (baseline to endpoint) via interaction with time using repeated measures
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 weeks (baseline to endpoint)Population: None of the subjects completed the study or made it to the 12 week endpoint.
Comparison between medication and placebo groups on the change in number of drinks per week via interaction with time (from baseline to endpoint) using repeated measures
Outcome measures
Outcome data not reported
Adverse Events
Zonisamide
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zonisamide
n=2 participants at risk
Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind
Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose
|
Placebo
n=1 participants at risk
Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group
Placebo: placebo
|
|---|---|---|
|
General disorders
Nervousness
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Feeling Drowsy
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Fatigue
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Psychiatric disorders
Depressed Mood
|
100.0%
2/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Skin and subcutaneous tissue disorders
Itching
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Reproductive system and breast disorders
Decreased Sex Drive
|
100.0%
2/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Psychiatric disorders
Mood swings
|
100.0%
2/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Psychiatric disorders
Restlessness
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Irritability
|
100.0%
2/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Psychiatric disorders
Confusion
|
100.0%
2/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Nervous system disorders
Memory Problems
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Nervous system disorders
Difficulty Paying attention
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Slowed Movements
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Swelling feet/ankles
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Gastrointestinal disorders
Gas
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Gait Disturbance
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Skin and subcutaneous tissue disorders
Decreased Sweating
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
General disorders
Extreme Thirst
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Metabolism and nutrition disorders
Loss of Appette
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Respiratory, thoracic and mediastinal disorders
Rapid Breathing
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Psychiatric disorders
Aggressive Behavior
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Psychiatric disorders
Difficulty Sleeping
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Nervous system disorders
Extreme Tiredness
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Reproductive system and breast disorders
Impotence
|
50.0%
1/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
0.00%
0/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/2 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
100.0%
1/1 • baseline, week 1, week 2
Adverse events reported on the SAFTEE form.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place