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A Study of Medication With or Without Psychotherapy for Complicated Grief (HEAL)

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ClinicalTrials.gov Identifier: NCT01179568
Recruitment Status : Completed
First Posted : August 11, 2010
Results First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Complicated Grief
Bereavement
Interventions Drug: Citalopram
Behavioral: Complicated Grief Treatment
Other: Placebo
Enrollment 395
Recruitment Details Bereaved individuals age 18-95 were recruited between March 2010 and September 2014 using professional and public outreach, print, broadcast and internet media. Referrals were made by health care professionals, bereavement counselors and patients or family members.
Pre-assignment Details  
Arm/Group Title Citalopram Placebo (Sugar Pill) CGT With Citalopram CGT With Placebo
Hide Arm/Group Description

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with SSRI medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with inactive medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

Period Title: Overall Study
Started 101 99 99 96
Completed Week 12 Assessment 69 69 76 75
Completed [1] 73 61 76 76
Not Completed 28 38 23 20
[1]
Week 20 assessment
Arm/Group Title Citalopram Placebo (Sugar Pill) CGT With Citalopram CGT With Placebo Total
Hide Arm/Group Description

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with SSRI medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with inactive medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

Total of all reporting groups
Overall Number of Baseline Participants 101 99 99 96 395
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 99 participants 99 participants 96 participants 395 participants
52.4  (13.1) 53.9  (13.8) 52.1  (15.3) 53.5  (16.0) 53.0  (14.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 99 participants 96 participants 395 participants
Female
82
  81.2%
69
  69.7%
78
  78.8%
79
  82.3%
308
  78.0%
Male
19
  18.8%
30
  30.3%
21
  21.2%
17
  17.7%
87
  22.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 99 participants 96 participants 395 participants
Hispanic or Latino
10
   9.9%
7
   7.1%
8
   8.1%
20
  20.8%
45
  11.4%
Not Hispanic or Latino
91
  90.1%
92
  92.9%
91
  91.9%
76
  79.2%
350
  88.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 99 participants 99 participants 96 participants 395 participants
While 85 80 81 79 325
Black 10 8 11 10 39
Others 6 11 7 7 31
1.Primary Outcome
Title Responder Status Based on Complicated Grief Clinical Global Impression-Improvement (CGI-I) Scale
Hide Description Brief rating scale frequently used in clinical trials. For this study, version modified for complicated grief was be used. Response is defined as a score of 1(very much improved) or 2 (much improved) on the scale. The rating was done by an Independent Evaluator.
Time Frame Weeks 12 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Response rates were compared under the intention-to-treat principle, including all randomized participants in a logistic regression with inverse probability weighting .
Arm/Group Title Citalopram (CIT) Placebo (PLA; Sugar Pill) Complicated Grief Treatment With Citalopram (CGT With CIT) Complicated Grief Treatment With Placebo (CGT With PLA)
Hide Arm/Group Description:

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Inactive medication. It is combined with grief-focused clinical management.

Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with SSRI medication.

Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with inactive medication.

Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

Overall Number of Participants Analyzed 101 99 99 96
Measure Type: Number
Unit of Measure: percentage of responders
46 38 84 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram (CIT), Placebo (PLA; Sugar Pill)
Comments Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants. With 10% of 440 target enrollment lost to follow-up we had a power of 76-83% to detect predicted between-group difference in response (CGT with PLA, 40%; CGT with CIT, 60%; CIT 40%; and PLA 20%)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) & race/ethnicity
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.82 to 1.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Complicated Grief Treatment With Citalopram (CGT With CIT), Complicated Grief Treatment With Placebo (CGT With PLA)
Comments Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs PLA with CGT at week 20 (aim 2) based on the intention-to-treat principle including all randomized participants.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) & race/ethnicity
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.88 to 1.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Citalopram (CIT), Complicated Grief Treatment With Citalopram (CGT With CIT)
Comments Our prespecified primary analysis was cross-sectional, comparing treatment response rates for CIT with CGT vs CIT at week 20 (aim 3) based on the intention-to-treat principle including all randomized participants.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression with inverse probability weighting controlled for randomization stratification variables (site and baseline MDD) & race/ethnicity
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
1 to 1.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Inventory of Complicated Grief (ICG)
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
Arm/Group Title Citalopram (CIT) Placebo (PLA; Sugar Pill)
Hide Arm/Group Description:

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

Overall Number of Participants Analyzed 101 99
Mean (Standard Deviation)
Unit of Measure: score change from baseline to wk12
18  (11) 16  (12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram (CIT), Placebo (PLA; Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Inventory of Complicated Grief (ICG)
Time Frame Baseline and week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Prespecified secondary analyses of self-report ratings of CG symptoms (ICG) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
Arm/Group Title Citalopram (CIT) Complicated Grief Treatment With Citalopram (CGT With CIT) Complicated Grief Treatment With Placebo (CGT With PLA)
Hide Arm/Group Description:

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with SSRI medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with inactive medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

Overall Number of Participants Analyzed 101 99 96
Mean (Standard Deviation)
Unit of Measure: score change from baseline to wk20
20  (12) 25  (14) 26  (12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Complicated Grief Treatment With Citalopram (CGT With CIT), Complicated Grief Treatment With Placebo (CGT With PLA)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .53
Comments Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.26
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.98
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Citalopram (CIT), Complicated Grief Treatment With Citalopram (CGT With CIT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Pre-specified secondary analyses compared changes in ICG scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.08
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Work and Social Adjustment Scale (WSAS)
Hide Description The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 12 score) for CIT vs PLA at week 12 (aim 1), based on the intention-to-treat principle including all randomized participants.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
Arm/Group Title Citalopram (CIT) Placebo (PLA; Sugar Pill)
Hide Arm/Group Description:

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

Overall Number of Participants Analyzed 101 99
Mean (Standard Deviation)
Unit of Measure: score change from baseline to wk12
10  (11) 8  (10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram (CIT), Placebo (PLA; Sugar Pill)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .59
Comments Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.57
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Work and Social Adjustment Scale (WSAS)
Hide Description The WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment. For the pre-specified analyses we compared change in the WSAS total score from baseline (calculated as baseline score minus week 20 score) for CIT with CGT vs PLA with CGT (aim 2), and for CIT with CGT vs CIT (aim 3) based on the intention-to-treat principle including all randomized participants.
Time Frame Baseline and week 20
Hide Outcome Measure Data
Hide Analysis Population Description
Prespecified secondary analyses of self-report ratings of grief-related functional impairment (WSAS) compared changes in scores using a weighted linear regression with inverse probability weighting to adjust for missing assessments.
Arm/Group Title Citalopram (CIT) Complicated Grief Treatment With Citalopram (CGT With CIT) Complicated Grief Treatment With Placebo (CGT With PLA)
Hide Arm/Group Description:

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with SSRI medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with inactive medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

Overall Number of Participants Analyzed 101 99 96
Mean (Standard Deviation)
Unit of Measure: score change from baseline to wk20
10  (12) 14  (10) 16  (11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Complicated Grief Treatment With Citalopram (CGT With CIT), Complicated Grief Treatment With Placebo (CGT With PLA)
Comments Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .40
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Citalopram (CIT), Complicated Grief Treatment With Citalopram (CGT With CIT)
Comments Pre-specified secondary analyses compared changes in WSAS scores using a weighted linear regression, controlling for site, baseline MDD, & race/ethnicity, and with inverse probability weighting to adjust for missing assessments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .005
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.13
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.46
Estimation Comments [Not Specified]
Time Frame 5 years
Adverse Event Reporting Description We observed no serious adverse medication effects. CGT therapists monitored participant response to emotionally activating procedures; no serious untoward responses were documented.
 
Arm/Group Title Citalopram Placebo (Sugar Pill) CGT With Citalopram CGT With Placebo
Hide Arm/Group Description

Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

Inactive medication. It is combined with grief-focused clinical management.

Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with SSRI medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion.

The targeted psychotherapy for complicated grief combined with inactive medication.

Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.

Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion.

All-Cause Mortality
Citalopram Placebo (Sugar Pill) CGT With Citalopram CGT With Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Citalopram Placebo (Sugar Pill) CGT With Citalopram CGT With Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/99 (0.00%)      1/99 (1.01%)      0/96 (0.00%)    
Injury, poisoning and procedural complications         
death by suicide * [1]  0/101 (0.00%)  0 0/99 (0.00%)  0 1/99 (1.01%)  1 0/96 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Review by the study team and Institutional Review Board determined that this death was not related to the research
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Citalopram Placebo (Sugar Pill) CGT With Citalopram CGT With Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/99 (0.00%)      0/99 (0.00%)      0/96 (0.00%)    
Two limitations of note: 1) FDA lowered the maximum safe dose of study medication (citalopram) after the study started; 2) our recruitment rate was 90% of target, while the assessment drop-out rate was over double what we expected.
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: M. Katherine Shear, MD
Organization: Columbia School of Social Work
Phone: 212-851-2176
EMail: ks2394@columbia.edu
Layout table for additonal information
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01179568     History of Changes
Other Study ID Numbers: 5971
R01MH060783 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2010
First Posted: August 11, 2010
Results First Submitted: September 6, 2016
Results First Posted: January 24, 2017
Last Update Posted: January 24, 2017