Zonisamide for Heavy Drinkers With Bipolar Disorder (ZNSBP)

This study has been terminated.
(recruitment infeasible)
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01566370
First received: December 15, 2011
Last updated: March 22, 2016
Last verified: March 2016
Results First Received: March 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alcohol Use Disorders
Bipolar Disorder
Interventions: Drug: Zonisamide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Zonisamide     Placebo  
STARTED     2     1  
COMPLETED     0     0  
NOT COMPLETED     2     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Heavy drinkers with bipolar disorder

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Zonisamide     Placebo     Total  
Number of Participants  
[units: participants]
  2     1     3  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     2     1     3  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Full Range)
  58.5  
  (57 to 60)  
  45  
  (45 to 45)  
  51.75  
  (45 to 60)  
Gender  
[units: participants]
     
Female     0     1     1  
Male     2     0     2  
Region of Enrollment  
[units: participants]
     
United States     2     1     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Total Heavy Drinking Days   [ Time Frame: from week 11 through 14 (over 4 weeks) ]

2.  Primary:   Change on Hamilton Depression Rating Scale   [ Time Frame: 14 weeks ]

3.  Secondary:   Percentage of Abstinent Days   [ Time Frame: over four weeks, from week 11 through 14 ]

4.  Secondary:   Change in Alcohol Urge Questionnaire Score   [ Time Frame: from baseline to endpoint, 14 weeks ]

5.  Secondary:   Change in Gamma Glutamyl Transferase (GGT)   [ Time Frame: 14 weeks ]

6.  Secondary:   Percentage of Total Drinking Days   [ Time Frame: 4 weeks ]

7.  Secondary:   Change in Number of Heavy Drinking Days Per Week by Time   [ Time Frame: 14 weeks (baseline to endpoint) ]

8.  Secondary:   Change in Number of Drinks Per Week by Time   [ Time Frame: 14 weeks (baseline to endpoint) ]

9.  Primary:   Change in Clinician Assisted Rating Scale for Mania (CARS-M) Scores   [ Time Frame: 14 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Change in Beck Depression Inventory (BDI) Scores   [ Time Frame: 14 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: albert.arias@va.gov



Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01566370     History of Changes
Other Study ID Numbers: ZNS-BP
VACT MIRECC ( Other Identifier: VA )
K23AA017689 ( US NIH Grant/Contract Award Number )
Study First Received: December 15, 2011
Results First Received: March 22, 2016
Last Updated: March 22, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration