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

NCT00550394 | Completed Phase 4 Results

• 2 other identifiers: NIAAAR21AA016372
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder; Alcohol Abuse

Keywords

Adolescents

Outcome Measures

Primary Outcomes (4)

• Drinks Per Day

  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

  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

  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

  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)

Study Arms (2)

Quetiapine and Placebo

ACTIVE COMPARATOR

Quetiapine and Placebo

Drug: quetiapine and placebo

Quetiapine and Topiramate

EXPERIMENTAL

Quetiapine and Topiramate

Drug: Quetiapine and Topiramate

Interventions

quetiapine and placebo DRUG

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.

Also known as: Quetiapine

Quetiapine and Placebo

Quetiapine and Topiramate DRUG

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.

Also known as: Topiramate

Quetiapine and Topiramate

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• 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;
• Any unstable medical illness or laboratory abnormalities \> 3 times upper limits of normal;
• 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;
• Any substance use other than alcohol, nicotine, or cannabis during the 30 days prior to study participation;
• A positive urine pregnancy test or lactating;
• History of nephrolithiasis.
• Treatment with concurrent mood stabilizers, antipsychotics or antidepressants;
• Treatment with antipsychotics or other mood stabilizers within 72 hours and antidepressants within 5 days prior to randomization;
• Treatment with fluoxetine within one month;
• A history of non-response or hypersensitivity to quetiapine or topiramate;
• 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);
• Treatment for substance use during 30 days prior to screening (excluding peer support groups);
• Court-ordered to substance use treatment;
• Acute intoxication;

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45227, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism

Interventions

Quetiapine Fumarate; Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Limitations and Caveats

Additional studies are needed as topiramate has not been systematically assessed. This study was to collect pilot data and more data will need to be collected.

Results Point of Contact

• Title: Melissa DelBello, MD, MS
• Organization: University of Cincinnati

delbelmp@uc.edu

513-558-2989

Study Officials

• Melissa P DelBello, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 29, 2007
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2014-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)