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Treatment for Bipolar Depression: Acute & Prophylactic Efficacy With Citalopram

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ClinicalTrials.gov Identifier: NCT00562861
Recruitment Status : Completed
First Posted : November 22, 2007
Results First Posted : February 13, 2017
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Tufts Medical Center

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
Enrollment 119
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mood Stabilizer Plus Citalopram Mood Stabilizer Plus Placebo
Hide Arm/Group Description 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 alone will be the treatment, with placebo used instead of double-blind citalopram.
Period Title: Overall Study
Started 60 59
Completed 40 48
Not Completed 20 11
Reason Not Completed
Adverse Event             1             1
Lack of Efficacy             5             5
noncompliance, moved             7             2
Lost to Follow-up             7             3
Arm/Group Title Mood Stabilizer Plus Citalopram Mood Stabilizer Plus Placebo Total
Hide Arm/Group Description citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers. Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers Total of all reporting groups
Overall Number of Baseline Participants 60 59 119
Hide Baseline Analysis Population Description
These subjects met inclusion/exclusion criteria and were randomized to citalopram versus placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 59 participants 119 participants
40.9  (12.6) 42.1  (11.3) 41.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 119 participants
Female
43
  71.7%
31
  52.5%
74
  62.2%
Male
17
  28.3%
28
  47.5%
45
  37.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 119 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 59 participants 119 participants
60 59 119
1.Primary Outcome
Title MADRS Rating Scale Change
Hide Description Montgomery Asberg Depression Rating scale assessed in mixed effects regression model. The total range for the scale is 0 to 60. Lower values involve less depression, while higher values involve worse depression. The change in the MADRS scale is interpreted as higher values meaning better outcomes, because more depressive symptoms are improved.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients randomized were analyzed in intent to treat manner.
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
Mood stabilizers given as part of standard treatment plus double-blind citalopram
Mood stabilizers given as part of standard treatment plus double-blind placebo
Overall Number of Participants Analyzed 60 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.1  (8.4) 15.2  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter F value
Estimated Value 1.88
Estimation Comments [Not Specified]
Time Frame Adverse events are reported for 1 year of follow-up during the randomized trial.
Adverse Event Reporting Description All patients were systematically interviewed for the adverse events reported.
 
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description Mood stabilizers given as part of standard treatment plus double-blind citalopram Mood stabilizers given as part of standard treatment plus double-blind placebo
All-Cause Mortality
Citalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/60 (1.67%)      0/59 (0.00%)    
Psychiatric disorders     
suicide * [1]  1/60 (1.67%)  1 0/59 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Subject committed suicide which was judged to be unrelated to administration of citalopram after review by investigators and evaluation by institutional review board.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/60 (38.33%)      15/59 (25.42%)    
Gastrointestinal disorders     
nausea   3/60 (5.00%)  3 6/59 (10.17%)  6
diarrhea   1/60 (1.67%)  1 5/59 (8.47%)  5
Nervous system disorders     
dry mouth   6/60 (10.00%)  6 0/59 (0.00%)  0
sexual dysfunction   5/60 (8.33%)  5 0/59 (0.00%)  0
headache   4/60 (6.67%)  4 6/59 (10.17%)  6
tremor   0/60 (0.00%)  0 4/59 (6.78%)  4
Psychiatric disorders     
sedation   8/60 (13.33%)  8 3/59 (5.08%)  3
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Nassir Ghaemi
Organization: Tufts Medical Center
Phone: 6176365735
EMail: nghaemi@tuftsmedicalcenter.org
Layout table for additonal information
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 )
First Submitted: November 20, 2007
First Posted: November 22, 2007
Results First Submitted: July 7, 2016
Results First Posted: February 13, 2017
Last Update Posted: March 24, 2017