Phase 4
Completed N=39
Efficacy and Tolerability of Topiramate in Treatment of Bipolar Mania and Alcohol Use in Adolescents and Young Adults
Bipolar Disorder · Alcohol Abuse
Source: ClinicalTrials.gov NCT00550394 ↗
Enrolled (actual)
39
Serious AEs
25.6%
Results posted
May 2017
Primary outcomePrimary: Drinks Per Day — -1.4; -2.4 Drinks per day
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drinks Per Day |
-1.4; -2.4 | — |
| PRIMARY Drinks Per Drinking Day |
-7.2; -7.3 | — |
| PRIMARY Percentage of Days Abstinent |
15; 14 | — |
| PRIMARY Percent Heavy Drinking Days |
-10; -14 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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 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;
- History of a medication change during the prior 30 days that may have precipitated manic symptoms;
- History of a partial response (any improvement) to any existing medications as reported by treating clinician, subjects or legal guardian.
Data sourced from ClinicalTrials.gov (NCT00550394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.