ClinicalTrials.gov
ClinicalTrials.gov Menu

Zonisamide for Heavy Drinkers With Bipolar Disorder (ZNSBP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01566370
Recruitment Status : Terminated (recruitment infeasible)
First Posted : March 29, 2012
Results First Posted : April 22, 2016
Last Update Posted : January 13, 2017
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcohol Use Disorders
Bipolar Disorder
Interventions Drug: Zonisamide
Drug: Placebo
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 2 1
Completed 0 0
Not Completed 2 1
Arm/Group Title Zonisamide Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
Heavy drinkers with bipolar disorder
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 3 participants
58.5
(57 to 60)
45
(45 to 45)
51.75
(45 to 60)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
0
   0.0%
1
 100.0%
1
  33.3%
Male
2
 100.0%
0
   0.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Percentage of Total Heavy Drinking Days
Hide Description 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).
Time Frame from week 11 through 14 (over 4 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change on Hamilton Depression Rating Scale
Hide Description Change from baseline to endpoint in Hamilton scores compared between medication and placebo, using repeated measures
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Change in Clinician Assisted Rating Scale for Mania (CARS-M) Scores
Hide Description 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
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percentage of Abstinent Days
Hide Description 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.
Time Frame over four weeks, from week 11 through 14
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in Alcohol Urge Questionnaire Score
Hide Description This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures
Time Frame from baseline to endpoint, 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Gamma Glutamyl Transferase (GGT)
Hide Description 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
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change in Beck Depression Inventory (BDI) Scores
Hide Description Comparison between groups on change in BDI scores over the 14 weeks of the study, measured weekly, using repeated measures
Time Frame 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Percentage of Total Drinking Days
Hide Description 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.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Change in Number of Heavy Drinking Days Per Week by Time
Hide Description 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
Time Frame 14 weeks (baseline to endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Change in Number of Drinks Per Week by Time
Hide Description 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
Time Frame 14 weeks (baseline to endpoint)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
None of the subjects completed the study or made it to the 12 week endpoint.
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame baseline, week 1, week 2
Adverse Event Reporting Description Adverse events reported on the SAFTEE form.
 
Arm/Group Title Zonisamide Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zonisamide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   1/1 (100.00%) 
Gastrointestinal disorders     
Diarrhea   1/2 (50.00%)  1/1 (100.00%) 
Gas   0/2 (0.00%)  1/1 (100.00%) 
General disorders     
Nervousness   1/2 (50.00%)  1/1 (100.00%) 
Feeling Drowsy   1/2 (50.00%)  1/1 (100.00%) 
Fatigue   1/2 (50.00%)  1/1 (100.00%) 
Irritability   2/2 (100.00%)  0/1 (0.00%) 
Slowed Movements   1/2 (50.00%)  0/1 (0.00%) 
Swelling feet/ankles   0/2 (0.00%)  1/1 (100.00%) 
Gait Disturbance   0/2 (0.00%)  1/1 (100.00%) 
Extreme Thirst   1/2 (50.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders     
Loss of Appette   1/2 (50.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders     
Leg Cramps   1/2 (50.00%)  1/1 (100.00%) 
Back pain   0/2 (0.00%)  1/1 (100.00%) 
Nervous system disorders     
Headache   1/2 (50.00%)  1/1 (100.00%) 
Memory Problems   1/2 (50.00%)  0/1 (0.00%) 
Difficulty Paying attention   1/2 (50.00%)  0/1 (0.00%) 
Extreme Tiredness   1/2 (50.00%)  1/1 (100.00%) 
Psychiatric disorders     
Depressed Mood   2/2 (100.00%)  0/1 (0.00%) 
Mood swings   2/2 (100.00%)  0/1 (0.00%) 
Restlessness   1/2 (50.00%)  0/1 (0.00%) 
Confusion   2/2 (100.00%)  0/1 (0.00%) 
Aggressive Behavior   1/2 (50.00%)  0/1 (0.00%) 
Difficulty Sleeping   1/2 (50.00%)  0/1 (0.00%) 
Reproductive system and breast disorders     
Decreased Sex Drive   2/2 (100.00%)  0/1 (0.00%) 
Breast Pain   0/2 (0.00%)  1/1 (100.00%) 
Impotence   1/2 (50.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion   0/2 (0.00%)  1/1 (100.00%) 
Rapid Breathing   0/2 (0.00%)  1/1 (100.00%) 
Chest pain   0/2 (0.00%)  1/1 (100.00%) 
Shortness of breath   0/2 (0.00%)  1/1 (100.00%) 
Skin and subcutaneous tissue disorders     
Rash   1/2 (50.00%)  0/1 (0.00%) 
Itching   1/2 (50.00%)  0/1 (0.00%) 
Decreased Sweating   1/2 (50.00%)  0/1 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Albert Arias
Organization: Yale/VA Connecticut Healthcare system
Phone: 2039325711 ext 8155
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01566370     History of Changes
Other Study ID Numbers: ZNS-BP
VACT MIRECC ( Other Identifier: VA )
K23AA017689 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2011
First Posted: March 29, 2012
Results First Submitted: March 22, 2016
Results First Posted: April 22, 2016
Last Update Posted: January 13, 2017