Clinical trial NCT00393978
Conditions: Bipolar Disorder Cannabis-Related Disorder
Keywords: Bipolar mania Cannabis consumption
Sponsor: University of Cincinnati
Start date: 2006-11-01; Completion date: 2014-03-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

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.

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.

Arms: arm 1: Quetiapine and Placebo arm 2: Quetiapine and Topiramate
Interventions: intervention 1: Quetiapine and placebo intervention 2: Quetiapine and Topiramate
Intervention descriptions: intervention 1: placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day). intervention 2: topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).

Protocol documents: