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Comparative Effectiveness Study for Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331304
First Posted: April 8, 2011
Last Update Posted: November 13, 2017
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.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Andrew A. Nierenberg, MD, Massachusetts General Hospital
Results First Submitted: January 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
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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 
Overall Participants Analyzed 
[Units: Participants]
 240   242   482 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.6  (12.1)   39.1  (12.2)   38.9  (12.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      140  58.3%      143  59.1%      283  58.7% 
Male      100  41.7%      99  40.9%      199  41.3% 
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: Average baseline score minus Average 6 month score ]

4.  Secondary:   Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)   [ Time Frame: Average baseline score minus Average 6-month score ]


  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: Dr. Andrew Nierenberg
Organization: Massachusetts General Hospital
phone: 617-724-0837
e-mail: anierenberg@mgh.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Andrew A. Nierenberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01331304     History of Changes
Other Study ID Numbers: 2010P001442
R01HS019371-01 ( U.S. AHRQ Grant/Contract )
First Submitted: April 6, 2011
First Posted: April 8, 2011
Results First Submitted: January 8, 2014
Results First Posted: June 4, 2014
Last Update Posted: November 13, 2017