Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02082678
Other study ID # 112013-075
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2014
Est. completion date May 2018

Study information

Verified date August 2021
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine if ondansetron, as an add-on therapy, is associated with reduced depressive symptoms and alcohol use in outpatients with bipolar disorder (BPD), cyclothymic disorder, schizoaffective disorder (bipolar type) and major depressive disorder (MDD) with mixed features. The investigators will also use blood samples to determine if the genotype for the serotonin transporter gene is associated with response to ondansetron.


Description:

A total of 70 outpatients with alcohol use disorder and BPD, cyclothymic disorder, schizoaffective disorder (bipolar type), or MDD with mixed features will be enrolled in a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of ondansetron. Participant will receive either ondansetron or a placebo for 12 weeks. He or she has an equal chance of receiving ondansetron or placebo. Randomization will be stratified based on > 4 or ≤ 4 drinking days per week at start of the study. Ondansetron or placebo will be given at 0.5 milligrams twice a day for the first 4 weeks. At weeks 4, 8 and 10 the dose may be increased to 1.0, 2.0 or 4.0 milligrams twice a day, respectively, if significant reductions in depression and alcohol use are not observed and the participant is not experiencing any side effects. Blood will be drawn for routine laboratory analyses including a complete blood count (CBC), liver panel, and Carbohydrate-deficient Transferrin (CDT) at baseline and weeks 4, 8 and 12. Each participant will return for weekly follow-up visits and repeat outcome measures. Pill counts will be conducted, and a list of current medications and doses will be recorded at each visit. Participants will be compensated at each appointment with a bus pass, gift cards, and a monetary incentive for compliance. Participants will be evaluated by both the research assistant (RA) and principal investigator (PI) at each visit. The Hamilton Rating Scale for Depression (HAMD) and Timeline Followback (TLFB) will be given at each visit as the primary outcome measures. Cognitive assessments will be performed at baseline and week 12.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
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)

Study Design


Intervention

Drug:
Ondansetron
Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.
Placebo
Inactive ingredient matching the active medication in appearance

Locations

Country Name City State
United States The University of Texas Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Rating Scale for Depression (HAMD) The Hamilton Rating Scale for Depression (HAMD) is a 17-item observer-rated measure of depressive symptomatology. HAMD is scored between 0 and 4 points, with the total score ranging from 0 to 52. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. The higher scores are associated with greater depressive symptom severity and poorer outcome. Baseline and Week 12
Primary Number of Standard Drinks Per Assessment Period on Timeline Followback (TLFB) The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB is interviewer-administered and asks participants to retrospectively estimate their alcohol use between each visit. The reported drinks are then converted to standard drinks based on the drink's alcohol by volume (ABV). The higher number is associated with more standard drinks and worse outcome. Values are corrected for the number of days covered in the assessment period. Baseline and Week 12
Primary Number of Heavy Drinking Days Per Assessment Period on Timeline Followback (TLFB) The Timeline Followback (TLFB) will be used to assess the change in the number of standard alcoholic drinks per week. The TLFB involves asking participants to retrospectively estimate their alcohol between each research visit. The reported drinks are then converted to heavy drinking days based on the drink's alcohol by volume (ABV) and participant's sex (male/female) - 5 drinks per day for males and 4 for females. Each day during which 4-5 drinks are consumed is counted as a heavy drinking day within a given assessment period. The reported values are corrected for days covered (divided by the number of days between each visit). The higher number is associated with more heavy drinking days and worse outcome. Baseline and Week 12
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2