Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With 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. Identifier: NCT00592852
Recruitment Status : Terminated (Slow subject recruitment.)
First Posted : January 14, 2008
Results First Posted : March 6, 2012
Last Update Posted : November 20, 2012
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Pediatric Bipolar Disorder
Pediatric OCD
Intervention: Drug: fluoxetine

  Participant Flow

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
Fluoxetine No text entered.

Participant Flow:   Overall Study
Non-compliance                1 
Adverse Event                3 
Found ineligible                1 
Withdrawal by Subject                1 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
Fluoxetine No text entered.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   12 
Between 18 and 65 years   1 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 12.46  (3.91) 
[Units: Participants]
Female   4 
Male   9 
Region of Enrollment 
[Units: Participants]
United States   13 

  Outcome Measures

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

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
No text entered.

  More Information

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

Responsible Party: Gagan Joshi, MD, Massachusetts General Hospital Identifier: NCT00592852     History of Changes
Other Study ID Numbers: 2005-P-001840
First Submitted: December 28, 2007
First Posted: January 14, 2008
Results First Submitted: July 28, 2011
Results First Posted: March 6, 2012
Last Update Posted: November 20, 2012