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Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT00562861
First received: November 20, 2007
Last updated: February 21, 2017
Last verified: February 2017
Results First Received: July 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Bipolar Depression
Interventions: Drug: citalopram + mood stabilizer
Drug: placebo + mood stabilizer

  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
Mood Stabilizer Plus Citalopram citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.
Mood Stabilizer Plus Placebo Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.

Participant Flow:   Overall Study
    Mood Stabilizer Plus Citalopram   Mood Stabilizer Plus Placebo
STARTED   60   59 
COMPLETED   40   48 
NOT COMPLETED   20   11 
Adverse Event                1                1 
Lack of Efficacy                5                5 
noncompliance, moved                7                2 
Lost to Follow-up                7                3 



  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.
These subjects met inclusion/exclusion criteria and were randomized to citalopram versus placebo.

Reporting Groups
  Description
Mood Stabilizer Plus Citalopram citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.
Mood Stabilizer Plus Placebo Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers
Total Total of all reporting groups

Baseline Measures
   Mood Stabilizer Plus Citalopram   Mood Stabilizer Plus Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   59   119 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.9  (12.6)   42.1  (11.3)   41.5  (11.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      43  71.7%      31  52.5%      74  62.2% 
Male      17  28.3%      28  47.5%      45  37.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.7%      0   0.0%      1   0.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      21  35.0%      20  33.9%      41  34.5% 
White      36  60.0%      35  59.3%      71  59.7% 
More than one race      2   3.3%      4   6.8%      6   5.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   60   59   119 


  Outcome Measures

1.  Primary:   MADRS Rating Scale Change   [ Time Frame: 6 weeks ]


  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: Nassir Ghaemi
Organization: Tufts Medical Center
phone: 6176365735
e-mail: nghaemi@tuftsmedicalcenter.org



Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00562861     History of Changes
Other Study ID Numbers: MH78060-01A1
5R01MH078060-04 ( U.S. NIH Grant/Contract )
Study First Received: November 20, 2007
Results First Received: July 7, 2016
Last Updated: February 21, 2017