Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania
Condition: Bipolar Disorder; Cannabis-Related Disorder
MeSH terms: Marijuana Abuse; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      The purpose of this research study is to study the effects (both good and bad) of combining
      medicines, called quetiapine and topiramate, for treating your symptoms, and other children
      and adolescents' symptoms, of bipolar mania (an illness with periods of elation, excessive
      excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless
      behavior). It is estimated that 1% of the population of adolescents in the United States has
      bipolar disorder. The purpose of this research study is also to study the effects (both good
      and bad) of combining the same two medicines, quetiapine and topiramate, for reducing your
      use, and other children and adolescents' use, of cannabis (commonly referred to as "pot"). It
      is estimated that 30.5% of adolescents in the United States have used cannabis at least once
      in their lifetime. Additionally, the purpose of this research is to look at how bipolar
      disorder and cannabis use effects brain chemicals and function.

      Quetiapine (marketed under the brand name Seroquel) has been approved by the FDA since 1997
      to help adults who suffer from schizophrenia (an illness of feeling, thought, perception and
      behavior). On January 12, 2004, the FDA approved quetiapine for the treatment of bipolar
      symptoms in adults. As of December 2009, Quetiapine has now been approved by the FDA for use
      in adolescents (13-17 years of age) for the treatment of schizophrenia and for the treatment
      of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years
      of age). Bipolar disorder is an illness characterized by recurrent mood swings including
      mania (i.e., periods of elation, excessive excitement, irritability, high energy, racing
      thoughts, poor sleep, poor judgment, reckless behavior) and clinical depression (i.e., a
      depressed mood, loss of interest in activities and disruption of sleep, appetite and energy).
      This study is being carried out to see if quetiapine is effective and safe for treatment of
      children and adolescents who have the symptoms of bipolar mania. This study is also being
      carried out to see if quetiapine, in combination with topiramate, will further reduce bipolar
      mania and reduce cannabis use.

      As of December 2, 2009, the US Food and Drug Administration (FDA) approved SEROQUEL
      (quetiapine fumarate) tablets for the treatment of schizophrenia in adolescents (13-17 years
      of age) as monotherapy, and for the acute treatment of manic episodes associated with bipolar
      I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an
      adjunct to lithium or divalproex.

      Topiramate (marketed under the brand name Topamax) is approved by the U.S. FDA for the
      prevention of migraine headaches in adults. The FDA has also approved topiramate for epilepsy
      (a seizure disorder) and for use as adjunctive therapy (meaning in combination with other
      medicines) for partial onset seizures in adults. Topiramate is not approved by the FDA for
      use in adults or for use in children and adolescents who have bipolar disorder. This study is
      being done to see if topiramate, in combination with quetiapine, will reduce bipolar mania
      and reduce cannabis use.

      The FDA has declared research studies with MRI field strengths up to and including 8 Tesla (a
      measure of field strength) as non-significant risk. This research study uses an MRI with a
      field strength of 4 Tesla.
    

Intervention name(s): Quetiapine and placebo; Quetiapine and Topiramate
Intervention type(s): Drug; Drug
Intervention description(s): placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).; topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
Other intervention name(s): quetiapine
Intervention MeSH terms: Topiramate; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar mania; Cannabis consumption