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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00550394
First received: October 25, 2007
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Alcohol Abuse
Drug: quetiapine + placebo
Drug: Quetiapine + Topiramate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occuring alcohol use and bipolar disorders. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: April 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Quitiapine + Placebo
Quetiapine + Placebo
Drug: quetiapine + 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 Name: Placebo
Experimental: Quitiapine + Topiramate
Quetiapine + Topiramate
Drug: Quetiapine + 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 Name: Topiramate

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.

  Eligibility

Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550394

Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45227
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Melissa P DelBello, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Melissa Delbello, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00550394     History of Changes
Other Study ID Numbers: NIAAA
Study First Received: October 25, 2007
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Adolescents

Additional relevant MeSH terms:
Alcohol Drinking
Bipolar Disorder
Alcoholism
Drinking Behavior
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Topiramate
Quetiapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014