Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania

NCT00393978 | Completed Phase 4 Results

• 2 other identifiers: NIDAR01DA022221
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to determine whether this treatment may be useful for reducing cannabis consumption; reducing symptoms of bipolar mania; and weight mitigation therapy for individuals on psychopharmacotherapy.

Conditions

Bipolar Disorder; Cannabis-Related Disorder

Keywords

Bipolar mania; Cannabis consumption

Outcome Measures

Primary Outcomes (2)

• Change in Joints Per Week

  Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.

  16 weeks

• Change in Percent Days of Cannabis Use Per Week

  Change in percent days of cannabis use per week from baseline to week 16.

  16 weeks

Study Arms (2)

Quetiapine and Placebo

PLACEBO COMPARATOR

Quetiapine and Placebo

Drug: Quetiapine and placebo

Quetiapine and Topiramate

ACTIVE COMPARATOR

Quetiapine and Topiramate

Drug: Quetiapine and Topiramate

Interventions

Quetiapine and placebo DRUG

placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).

Also known as: quetiapine

Quetiapine and Placebo

Quetiapine and Topiramate DRUG

topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Quetiapine and Topiramate

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• have an authorized parent/legal guardian who understands the nature of the study and who provides written informed consent if the study subject is younger than 18 years of age. Additionally, each subject must provide assent to the study;
• be fluent in English;
• be 12 to 21 years of age, inclusive;
• be using a medically accepted means of contraception (i.e., oral contraceptives and barrier methods (diaphragm or condom), medroxyprogesterone acetate injectable suspension, abstinence) if female and of menarche. Oral contraceptives alone are not acceptable means of contraception because concomitant use of topiramate and low estrogen oral contraceptive pills may lead to oral contraceptive failure;
• have a diagnosis of bipolar I disorder in a current manic or mixed episode, in addition to a cannabis use disorder (which includes abuse or dependence) within 28 days prior to screening, as determined by the WASH-U-KSADS;
• have an initial YMRS total score of \>16 at screening and baselines;
• use cannabis a minimum of twice per week on average during the 28 days prior to screening.
• have a known history of mental retardation;
• are acutely intoxicated, and thus impaired;
• have manic or depressive symptoms resulting entirely from acute medical illness or acute intoxication or withdrawal from drugs or alcohol, as determined by medical evaluation and rapid symptom resolution;
• have clinically significant alcohol or other drug withdrawal symptoms, as determined by vital signs, The Clinical Institute Withdrawal Assessment for Alcohol Scale - Revised (CIWA-Ar)24, and physician interview;
• have any unstable medical or neurological illness as determined by a study physician;
• have laboratory abnormalities \>3 times upper limits of established normal values;
• as females, have a positive serum (screening and week 16) or urine pregnancy test (at baseline and weeks 1-16), are lactating, or are not practicing a reliable form of birth control;
• have a history of nephrolithiasis, since topiramate has been associated with an elevated risk of kidney stones;

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219-0516, United States

Location

Related Publications (1)

• Farrow JE, DelBello MP, Patino LR, Blom TJ, Welge JA. A Double-Blind, Placebo-Controlled Study of Adjunctive Topiramate in Adolescents With Co-Occurring Bipolar and Cannabis Use Disorders. JAACAP Open. 2024 Sep 7;2(4):290-300. doi: 10.1016/j.jaacop.2024.08.002. eCollection 2024 Dec.

  PMID: 39697396 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Marijuana Abuse

Interventions

Quetiapine Fumarate; Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental 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

Results Point of Contact

• Title: Melissa P. DelBello, MD
• Organization: University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience

Melissa.DelBello@uc.edu

513-558-2989

Study Officials

• Melissa P DelBello, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 30, 2006
• First Posted: October 31, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2014
• Last Updated: September 26, 2017
• Results First Posted: August 29, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)