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Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149799
First Posted: September 8, 2005
Last Update Posted: December 5, 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.
Collaborators:
National Institute of Mental Health (NIMH)
Rhode Island Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
Results First Submitted: October 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Anxiety Disorders
Somatoform Disorders
Interventions: Drug: Escitalopram
Drug: Placebo

  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
A total of 100 participants received open-label escitalopram in Phase I. Only those who completed Phase I, met criteria for response, and were willing to continue on in the study were subsequently randomized in Phase II (n=58).

Reporting Groups
  Description
Phase I: Open-Label Escitalopram Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
Phase II: Double-blind Escitalopram At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
Phase II: Double-blind Placebo At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.

Participant Flow for 2 periods

Period 1:   Open Label Escitalopram (Phase I)
    Phase I: Open-Label Escitalopram   Phase II: Double-blind Escitalopram   Phase II: Double-blind Placebo
STARTED   100   0   0 
COMPLETED   74 [1]   0   0 
NOT COMPLETED   26   0   0 
[1] 14 completers were non-responders and 2 responders terminated the study after completing Phase I

Period 2:   Discontinuation (Phase II)
    Phase I: Open-Label Escitalopram   Phase II: Double-blind Escitalopram   Phase II: Double-blind Placebo
STARTED   0   28 [1]   30 [1] 
COMPLETED   0   25   21 
NOT COMPLETED   0   3   9 
[1] Only responders who completed Phase I and were willing to continue were randomized in Phase II



  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.
As the primary endpoint is based on participants randomized to Phase II (i.e. those who completed Phase I, met criteria for response, and were willing to continue on in the study), baseline characteristics are provided for the 58 Phase II participants.

Reporting Groups
  Description
Phase II: Escitalopram At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
Phase II: Placebo At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
Total Total of all reporting groups

Baseline Measures
   Phase II: Escitalopram   Phase II: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   30   58 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (12.4)   31.8  (13.5)   33.5  (12.4) 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      1   3.3%      1   1.7% 
Between 18 and 65 years      27  96.4%      28  93.3%      55  94.8% 
>=65 years      1   3.6%      1   3.3%      2   3.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      20  71.4%      20  66.7%      40  69.0% 
Male      8  28.6%      10  33.3%      18  31.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   3.3%      1   1.7% 
Asian      1   3.6%      0   0.0%      1   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   3.6%      1   3.3%      2   3.4% 
White      24  85.7%      27  90.0%      51  87.9% 
More than one race      2   7.1%      1   3.3%      3   5.2% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      4  14.3%      5  16.7%      9  15.5% 
Not Hispanic or Latino      24  85.7%      24  80.0%      48  82.8% 
Unknown or Not Reported      0   0.0%      1   3.3%      1   1.7% 
Region of Enrollment 
[Units: Participants]
     
United States   28   30   58 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)   [ Time Frame: Phase II: Biweekly for six months after randomization ]

2.  Secondary:   Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)   [ Time Frame: Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14 ]

3.  Secondary:   Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)   [ Time Frame: Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40 ]

4.  Secondary:   Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)   [ Time Frame: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40) ]

5.  Secondary:   Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)   [ Time Frame: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40) ]


  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
Our findings may not be fully generalizable - for example, we excluded those with a co-occurring substance use disorder, higher levels of suicidality, and more severely ill patients who required concomitant therapy or a higher level of care.


  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: Katharine A. Phillips, MD
Organization: Rhode Island Hospital
phone: 401-444-1646
e-mail: katharine_phillips@brown.edu



Responsible Party: Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00149799     History of Changes
Other Study ID Numbers: R01MH072854 ( U.S. NIH Grant/Contract )
2004-P-002305 ( Other Identifier: IRB Protocol Number )
DSIR 83-ATSO
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: October 17, 2014
Results First Posted: November 21, 2014
Last Update Posted: December 5, 2017