Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults

April 21, 2017 updated by: Melissa Delbello, University of Cincinnati

Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults

The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder.

Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in alcohol consumption (number of drinks per day, number of drinks per drinking day, and number of heavy drinking days) and greater abstinence (percentage of days abstinent) compared with quetiapine alone.

Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders.

Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • University of Cincinnati Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 12-25 years;
  2. DSM-IV-TR83 criteria for bipolar disorder, type I, manic or mixed episode;
  3. Young Mania Rating Scale (YMRS)86-88 score of > 16 at screening and baseline visits;
  4. DSM-IV-TR83 criteria for current alcohol abuse or dependence;

  5. Drinking >8 drinks in 30 days within the previous 6 months while meeting DSM-IV criteria for alcohol abuse or dependence.

    One standard drink is defined as 0.35 liters of beer, 0.15 liters of wine, or 0.04 liters of 80-proof liquor;

  6. Fluent in English;
  7. Provision of written informed consent/assent; 8) If female and of child bearing potential, agrees to use one of the following method of birth control: complete abstinence, barrier (diaphragm or condom), or oral contraceptive containing > 35 micrograms of ethinyl estradiol (because concomitant use of topiramate and lower estrogen oral contraceptives may lead to contraceptive failure).

Exclusion Criteria:

  1. Manic symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol as determined by medical evaluation and rapid symptom resolution;
  2. Clinically significant alcohol or drug withdrawal symptoms that have the potential to cause serious consequences as determined by vital signs, the CIWA-Ar,84 and medical evaluation;
  3. Any unstable medical illness or laboratory abnormalities > 3 times upper limits of normal;
  4. A documented history of mental retardation or an IQ total score < 70 as determined by the Wechsler Abbreviated Scale of Intelligence (WASI),154 administered by a trained psychometrician;
  5. Any substance use other than alcohol, nicotine, or cannabis during the 30 days prior to study participation;
  6. A positive urine pregnancy test or lactating;
  7. History of nephrolithiasis.
  8. Treatment with concurrent mood stabilizers, antipsychotics or antidepressants;
  9. Treatment with antipsychotics or other mood stabilizers within 72 hours and antidepressants within 5 days prior to randomization;
  10. Treatment with fluoxetine within one month;
  11. A history of non-response or hypersensitivity to quetiapine or topiramate;
  12. Serious suicidal ideation (> 3 on the CDRS-R89 suicide item, or any serious suicide attempt within the prior 60 days as judged by the investigator; 3=has thoughts about suicide or hurting themselves usually when angry);
  13. Treatment for substance use during 30 days prior to screening (excluding peer support groups);
  14. Court-ordered to substance use treatment;
  15. Acute intoxication;
  16. History of a medication change during the prior 30 days that may have precipitated manic symptoms;
  17. History of a partial response (any improvement) to any existing medications as reported by treating clinician, subjects or legal guardian.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Quetiapine and Placebo
Drug: quetiapine and placebo

Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Other Names:
  • Quetiapine
Experimental: Quetiapine and Topiramate
Drug: Quetiapine and Topiramate

Dosing Schedule and Titration of Quetiapine:

open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Other Names:
  • Topiramate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks Per Day
Time Frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period).
baseline to 12 weeks or endpoint (up to 11 weeks)
Drinks Per Drinking Day
Time Frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period)
baseline to 12 weeks or endpoint (up to 11 weeks)
Percentage of Days Abstinent
Time Frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period).
baseline to 12 weeks or endpoint (up to 11 weeks)
Percent Heavy Drinking Days
Time Frame: baseline to 12 weeks or endpoint (up to 11 weeks)
Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period).
baseline to 12 weeks or endpoint (up to 11 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Melissa P DelBello, MD, University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 29, 2007

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA
  • R21AA016372 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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