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Allopurinol Maintenance Study for Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00732251
Recruitment Status : Terminated (The outpatient area of the department of psychiatry at CSMC closed.)
First Posted : August 11, 2008
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
West Coast College of Biological Psychiatry Inc
Information provided by (Responsible Party):
Itai Danovitch, Cedars-Sinai Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Bipolar Disorder
Mixed Mania
Intervention: Drug: Allopurinol

  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
7 subjects screen failed.

Reporting Groups
Allopurinol Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period

Participant Flow:   Overall Study
Lost to Follow-up                3 
Withdrawal by Subject                3 
Early Term due to Site Closure                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
Allopurinol Allopurinol: Allopurinol: 300-600 mg/day over a 24 month period

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      8 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      3  37.5% 
Male      5  62.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      1  12.5% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      7  87.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      1  12.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1  12.5% 
White      2  25.0% 
More than one race      0   0.0% 
Unknown or Not Reported      4  50.0% 
Region of Enrollment 
[Units: Participants]
United States   8 

  Outcome Measures

1.  Primary:   Young Mania Rating Scale (YMRS)   [ Time Frame: 2 Years ]

2.  Secondary:   Hamilton Depression Scale (HAM-D)   [ Time Frame: 2 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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: Felicia Mayes
Organization: Cedars Sinai Medical Center
phone: 310-423-0825
e-mail: mayesf@cshs.org

Responsible Party: Itai Danovitch, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00732251     History of Changes
Other Study ID Numbers: IRB13414
First Submitted: August 7, 2008
First Posted: August 11, 2008
Results First Submitted: January 25, 2018
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018