Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder

This study has been terminated.
(Slow subject recruitment.)
Sponsor:
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00592852
First received: December 28, 2007
Last updated: November 13, 2012
Last verified: November 2012
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pediatric Bipolar Disorder
Pediatric OCD
Intervention: Drug: fluoxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fluoxetine No text entered.

Participant Flow:   Overall Study
    Fluoxetine  
STARTED     13  
COMPLETED     7  
NOT COMPLETED     6  
Non-compliance                 1  
Adverse Event                 3  
Found ineligible                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Fluoxetine No text entered.

Baseline Measures
    Fluoxetine  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     12  
Between 18 and 65 years     1  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  12.46  ± 3.91  
Gender  
[units: participants]
 
Female     4  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     13  



  Outcome Measures
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1.  Primary:   Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)   [ Time Frame: weekly ]

2.  Secondary:   Young Mania Rating Scale (YMRS)   [ Time Frame: weekly ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gagan Joshi, MD
Organization: Massachusetts General Hospital
phone: 617-503-1084
e-mail: joshi.gagan@mgh.harvard.edu


No publications provided


Responsible Party: Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592852     History of Changes
Other Study ID Numbers: 2005-P-001840
Study First Received: December 28, 2007
Results First Received: July 28, 2011
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board