Ondansetron for Bipolar Disorder and Alcohol Use Disorders

Plain-language summary

This study evaluates Ondansetron compared with a placebo in adults who have both a bipolar-spectrum mood disorder and an alcohol use disorder. Outpatients aged 18-70 on stable mood-stabilizer therapy with recent alcohol use were able to take part. The study was carried out in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

University of Texas Southwestern Medical Center

Intervention

Ondansetron, Placebo

Start date

2/1/2014

Estimated completion

5/1/2018

Countries

United States

Related genes

Locations

• Dallas, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Outpatient men and women age 18-70 years old with bipolar I, II, or Not Otherwise Specified (NOS) disorders, schizoaffective disorder (bipolar type), cyclothymic disorder, or major depressive disorder with mixed features
* Current diagnosis of alcohol use disorder (DSM V terminology) with onset ≤ age 25
* Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to intake
* IF diagnosis of Bipolar I, II, or NOS Disorder: Current mood stabilizer therapy (lithium, anticonvulsant, atypical antipsychotic) with stable dose for at least 14 days prior to randomization
* IF diagnosis of Schizoaffective disorder (bipolar type): Current atypical antipsychotic therapy with stable dose for at least 14 days prior to randomization
* IF diagnosis of Major Depressive Disorder with mixed features: Current antidepressant therapy with stable dose for at least 14 days prior to randomization

Exclusion Criteria:

* Baseline Young Mania Rating Scale (YMRS) or Hamilton Rating Scale for Depression (HAMD) scores ≥ 35 to exclude those with very severe mood symptoms
* Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar (Clinical Institute Withdrawal Assessment of Alcohol Use-Revised) score of ≥ 10
* Therapy in past 14 days with naltrexone, acamprosate, disulfiram, or topiramate
* Vulnerable populations (e.g. pregnant, breastfeeding, incarcerated, cognitively impaired (e.g. dementia, mentally challenged))
* High risk of suicide defined as \> 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
* Intensive outpatient treatment (defined as ≥ 3 visits each week) for substance abuse (AA, NA meetings, or less intensive counseling at baseline will be allowed)
* Severe or life-threatening medical condition (e.g., hepatic cirrhosis) or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
* AST (aspartate aminotransferase ) or ALT (alanine transaminase) \> 3 times the upper limit of normal
* History of severe side effects or allergic reaction with prior ondansetron therapy (e.g. for vomiting) or use of medications with significant drug-drug interactions with ondansetron (phenytoin, carbamazepine, and rifampicin, apomorphine, tramadol)