Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania
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|ClinicalTrials.gov Identifier: NCT00393978|
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : August 29, 2017
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Cannabis-Related Disorder||Drug: Quetiapine and placebo Drug: Quetiapine and Topiramate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Cannabis Use in Adolescents|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||March 2014|
Placebo Comparator: Quetiapine and Placebo
Quetiapine and Placebo
Drug: Quetiapine and placebo
placebo (titrated to 150-300 mg/day) in combination with quetiapine (titrated to 400-800 mg/day).
Other Name: quetiapine
Active Comparator: Quetiapine and Topiramate
Quetiapine and Topiramate
Drug: Quetiapine and Topiramate
topiramate (titrated to 150-300 mg/day) in combination with Quetiapine (titrated to 400-800 mg/day).
- Change in Joints Per Week [ Time Frame: 16 weeks ]Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks.
- Change in Percent Days of Cannabis Use Per Week [ Time Frame: 16 weeks ]Change in percent days of cannabis use per week from baseline to week 16.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393978
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45219-0516|
|Principal Investigator:||Melissa P DelBello, MD||University of Cincinnati|