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Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania
This study is currently recruiting participants.
Verified by University of Cincinnati, July 2008
Sponsors and Collaborators: University of Cincinnati
Eli Lilly and Company
Information provided by: University of Cincinnati
ClinicalTrials.gov Identifier: NCT00393978
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Cannabis-Related Disorder
Drug: quetiapine
Drug: topiramate
Phase IV

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Topiramate Quetiapine Quetiapine fumarate Cannabis GW-1000
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • To determine whether this treatment may be useful for reducing cannabis consumption. To determine whether this treatment may be useful for reducing symptoms of bipolar mania. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether this treatment may be useful in weight mitigation therapy for individuals on psychopharmacotherapy. [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: quetiapine
    titrated to 150-300 mg/day
    Drug: topiramate
    titrated to 400-600 mg/day
  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have an authorized parent/legal guardian who understands the nature of the study and who provides written informed consent. Additionally, each subject must provide assent to the study;
  • be fluent in English;
  • be 12 to 20 years of age, inclusive;
  • be using a medically accepted means of contraception (i.e., oral contraceptives, medroxyprogesterone acetate injectable suspension, abstinence) if female and of menarche;
  • 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.

Exclusion Criteria:

  • have a diagnosis of mental retardation, as defined by the Weschler Abbreviated Scale of Intelligence (WASI)38 score of <70;
  • 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;
  • have laboratory abnormalities >3 times upper limits of established normal values;
  • as females, have a positive urine pregnancy test, 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;
  • have concurrent treatment with mood stabilizers, anticonvulsants, psychostimulants, or antidepressants, so that we can examine the effects of topiramate vs. placebo in combination with QT in a controlled study
  • have significant suicidal ideation, as defined by a score of > 3 on the Children's Depression Rating Scale-Revised CDRS34 suicide item, or any serious suicide attempt within the prior 60 days as judged by the investigator so that we do not include patients with a high risk for suicide attempts during study participation
  • have been treated for a substance use disorder during 28 days prior to screening or are court-ordered to treatment for substance use to ensure that, if we detect a change in use with topiramate treatment, it is likely not due to these other confounding factors that might influence substance use.
  • have been diagnosed or treated for an eating disorder, to make sure any weight loss does not contribute to an already underlying condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00393978

Contacts
Contact: Jen Bell, BA 513-558-6195 jennifer.bell@psychiatry.uc.edu

Locations
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267-0559
Contact: Allison Albertz, RN     513-558-4812     allison.albertz@psychiatry.uc.edu    
Principal Investigator: Melissa P DelBello, MD            
Sponsors and Collaborators
University of Cincinnati
Eli Lilly and Company
Investigators
Principal Investigator: Melissa P DelBello, MD University of Cincinnati
  More Information

Responsible Party: University of Cincinnati ( Melissa P. DelBello, MD )
Study ID Numbers: 1 R01 DA022221-01
Study First Received: October 30, 2006
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00393978  
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Bipolar mania
Cannabis consumption

Study placed in the following topic categories:
Quetiapine
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Substance-Related Disorders
Mood Disorders
Topiramate
Disorders of Environmental Origin
Psychotic Disorders
Marijuana Abuse

Additional relevant MeSH terms:
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 14, 2009