Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

This study has been completed.
Sponsor:
Collaborators:
Rhode Island Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00149799
First received: September 6, 2005
Last updated: November 14, 2014
Last verified: November 2014
Results First Received: October 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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: 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.

Participant Flow for 2 periods

Period 1:   Open Label Escitalopram (Phase I)
    Phase I: Open-Label Escitalopram     Phase II: Escitalopram     Phase II: 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: Escitalopram     Phase II: Placebo  
STARTED     0     28 [1]   30 [1]
COMPLETED     0     25     21  
NOT COMPLETED     0     3     9  
[1] Only responders who completed Phase I 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  
Number of Participants  
[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]
     
<=18 years     0     1     1  
Between 18 and 65 years     27     28     55  
>=65 years     1     1     2  
Gender  
[units: participants]
     
Female     20     20     40  
Male     8     10     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     1     2  
White     24     27     51  
More than one race     2     1     3  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     4     5     9  
Not Hispanic or Latino     24     24     48  
Unknown or Not Reported     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     28     30     58  



  Outcome Measures
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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:   Q-LES-Q Short Form   [ Time Frame: Measured four times throughout study (Weeks 0, 14, 28, and 40) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Psychosocial Functioning (as Measured by the LIFE-RIFT)   [ Time Frame: Measured four times throughout study (Weeks 0, 14, 28, and 40) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Depressive Symptoms (as Measured by the HAM-D)   [ Time Frame: Measured biweekly for six months after randomization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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


No publications provided


Responsible Party: Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00149799     History of Changes
Other Study ID Numbers: R01 MH072854, R01MH072854, 2004-P-002305, DSIR 83-ATSO
Study First Received: September 6, 2005
Results First Received: October 17, 2014
Last Updated: November 14, 2014
Health Authority: United States: Federal Government