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Tracking Information | |||||
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First Received Date † | October 30, 2006 | ||||
Last Updated Date | February 17, 2009 | ||||
Start Date † | November 2006 | ||||
Current 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 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00393978 on ClinicalTrials.gov Archive Site | ||||
Current 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 ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania | ||||
Official Title † | Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Cannabis Use in Adolescents | ||||
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. |
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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. Quetiapine is not approved by the FDA for use in children and adolescents who have bipolar disorder. 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. Topiramate (marketed under the brand name Topomax) 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. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | Placebo Comparator: Quetiapine + Placebo vs. Quetiapine + Topiramate | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 90 | ||||
Estimated Completion Date | December 2011 | ||||
Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Peer support groups are not considered treatment for substance use. **Patients can be enrolled into the study that are already enrolled in a court ordered substance treatment, for at least 1 month prior to study enrollment, if they still meet the minimum cannabis use criterion.**• have been diagnosed or treated for an eating disorder, to make sure any weight loss does not contribute to an already underlying condition |
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Gender | Both | ||||
Ages | 12 Years to 20 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00393978 | ||||
Responsible Party | Melissa P. DelBello, MD, University of Cincinnati | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Cincinnati | ||||
Collaborators †† | National Institute on Drug Abuse (NIDA) | ||||
Investigators † |
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Information Provided By | University of Cincinnati | ||||
Verification Date | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |