Comparative Effectiveness Study for Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01331304
First received: April 6, 2011
Last updated: May 23, 2014
Last verified: May 2014
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: Lithium
Drug: Quetiapine

  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
Li + APT

Study participants will take lithium in addition to any other medications recommended by the study physician.

Lithium: 600-1200mg per day over 6 months

QTP + APT

Study participants will take quetiapine in addition to any other medications recommended by the study physician.

Quetiapine: 100-800mg a day over 6 months


Participant Flow:   Overall Study
    Li + APT     QTP + APT  
STARTED     240     242  
COMPLETED     182     182  
NOT COMPLETED     58     60  



  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.
No text entered.

Reporting Groups
  Description
Li + APT

Study participants will take lithium in addition to any other medications recommended by the study physician.

Lithium: 600-1200mg per day over 6 months

QTP + APT

Study participants will take quetiapine in addition to any other medications recommended by the study physician.

Quetiapine: 100-800mg a day over 6 months

Total Total of all reporting groups

Baseline Measures
    Li + APT     QTP + APT     Total  
Number of Participants  
[units: participants]
  240     242     482  
Age  
[units: Years]
Mean ± Standard Deviation
  38.6  ± 12.1     39.1  ± 12.2     38.9  ± 12.1  
Gender  
[units: participants]
     
Female     140     143     283  
Male     100     99     199  
Region of Enrollment  
[units: participants]
     
United States     240     242     482  



  Outcome Measures
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1.  Primary:   Clinical Global Impression-Efficacy Index (CGI-EI)   [ Time Frame: Average 6 month score minus Average baseline score ]

2.  Primary:   Necessary Clinical Adjustments   [ Time Frame: 6 Months ]

3.  Secondary:   Risk of Cardiovascular Disease - Framingham Risk Score   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Andrew Nierenberg
Organization: Massachusetts General Hospital
phone: 617-724-0837
e-mail: anierenberg@mgh.harvard.edu


No publications provided


Responsible Party: Andrew A. Nierenberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01331304     History of Changes
Other Study ID Numbers: R01 HS019371-01
Study First Received: April 6, 2011
Results First Received: January 8, 2014
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board