Treatment and Outcome of Early Onset Bipolar Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00048802|
Recruitment Status : Completed
First Posted : November 13, 2002
Last Update Posted : January 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder||Drug: Lithium Drug: Olanzapine Drug: Divalproex Drug: Risperidone Drug: Quetiapine Drug: Ziprasidone Drug: Aripriprazole||Phase 4|
In children and adolescents, bipolar disorder is often accompanied by symptoms such as hallucinations, delusions, or paranoia that require acute treatment with a combination of an atypical antipsychotic medication and a mood stabilizer. It is not known if it is necessary to continue treatment with the atypical antipsychotic medication after the child's symptoms have remitted.
Participants in this study are treated with lithium, divalproex (Depakote), and one of the following atypical antipsychotic medications: olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel) for at least 24 weeks. Participants who have already begun combination therapy with at least one of the mood stabilizers and atypical antipsychotic medications listed above are also encouraged to enroll in this study. After participants have been on combination therapy for at least 24 weeks they will then be randomly assigned to one of two groups. The first group will continue to receive active mood stabilizer and atypical antipsychotic medication. The second group will receive active mood stabilizer and placebo. Participants are assessed weekly and followed for up to 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treatment and Outcome of Early Onset Bipolar Disorder|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
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): NCT00048802
|United States, New York|
|The Zucker Hillside Hospital, Long Island Jewish Medical Center|
|Glen Oaks, New York, United States, 11004|