Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393978
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2006-10-30
Brief Title:
Efficacy Study of Quetiapine Plus Topiramate for Reducing Cannabis Consumption and Bipolar Mania
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
Quetiapine Plus Topiramate or Placebo for Bipolar Mania Cannabis Use in Adolescents
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 305 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 ie periods of elation excessive excitement irritability high energy racing thoughts poor sleep poor judgment reckless behavior and clinical depression ie 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 US 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
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 ie periods of elation excessive excitement irritability high energy racing thoughts poor sleep poor judgment reckless behavior and clinical depression ie 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 US 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA022221 | NIH | None | httpsreporternihgovquickSearchR01DA022221 |