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Trial record 5 of 12 for:    "Somatoform Disorder" | "Serotonin Agents"

CBT as an Adjunct to SRIs in the Treatment of BDD

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ClinicalTrials.gov Identifier: NCT00211809
Recruitment Status : Terminated (low enrollment)
First Posted : September 21, 2005
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Body Dysmorphic Disorder
Interventions Behavioral: Cognitive Behavioral Therapy
Drug: Venlafaxine
Enrollment 17
Recruitment Details Subjects were recruited by advertising and other media and by referral from outside clinicians.
Pre-assignment Details  
Arm/Group Title Body Dysmorphic Disorder
Hide Arm/Group Description

Participants with body dysmorphic disorder

Standard Psychiatric Evaluation

Venlafaxine: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.

Period Title: Overall Study
Started 17
Completed 11
Not Completed 6
Reason Not Completed
Lack of Efficacy             1
Lost to Follow-up             2
Pregnancy             1
side effects             2
Arm/Group Title Body Dysmorphic Disorder
Hide Arm/Group Description Participants with body dysmorphic disorder
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
29.7  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
15
  88.2%
Male
2
  11.8%
SSRI history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
SSRI naive
7
  41.2%
prior failed SSRI trials
10
  58.8%
1.Primary Outcome
Title Body Dysmorphic Disorder Examination
Hide Description Body Dysmorphic Disorder Examination - Self Reported (BDDE-SR) score - The BDDE-SR is a 30-item self-rating of BDD symptoms, with a more specific measure of body image dissatisfaction. Each item is rated 0 (no dissatisfaction to 6 (extreme dissatisfaction), with total score from 0 to 180.
Time Frame baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Endpoint
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Participants with Body Dysmorphic Disorder at baseline
Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
113.91  (27.41) 107.73  (39.93)
2.Primary Outcome
Title Yale Brown Obsessive Scale
Hide Description Yale Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) - a 12-item semistructured clinician-rated instrument designed to rate severity of body dysmorphic disorder (BDD) symptoms during the past week. The score for each item ranges from 0 (no symptoms) to 4 (extreme symptoms). The BDD-YBOCS Obsession Subtotal score range is 0-20 and the BDD-YBOCS Compulsion Subtotal score range is 0-20. The BDD-YBOCS Insight/Avoidance Subtotal score range is 0-8. The total BDD-YBOCS score range is from 0 (not present or extremely mild) to 48 (severe). Each item is rated as a composite of all the patient's appearance related obsessions and compulsive behaviors independent of their content.
Time Frame baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Endpoint
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Participants with Body Dysmorphic Disorder at baseline
Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Psychiatrist's Ratings for Total 34.64  (5.09) 26.55  (11.28)
Psychiatrist's Ratings for Obsessions 14.73  (2.20) 11.45  (5.03)
Psychiatrist's Ratings for Compulsions 14.82  (1.20) 11.55  (4.93)
Psychologist's Ratings for Total 35.91  (4.21) 28.27  (9.49)
Psychologist's Ratings for Obsessions 14.45  (4.57) 12.09  (4.72)
Psychologist's Ratings for Compulsions 16.09  (2.30) 12.18  (3.84)
3.Primary Outcome
Title Body Dysmorphic Disorder Clinical Global Impressions Scale
Hide Description The Clinical Global Impression-Improvement Scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time Frame baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Body Dysmorphic Disorder
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Participants with body dysmorphic disorder after Venlafaxine treatment up to 16 weeks
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Psychiatrist's Ratings 2.73  (0.91)
Psychologist's Ratings 3.00  (1.00)
4.Secondary Outcome
Title Brown Assessment of Beliefs Scale
Hide Description The Brown Assessment of Beliefs Scale (BABS) rates the degree of conviction and insight patients have concerning their beliefs. The BABS consists of 7 items: the first 6 items are added to obtain the total BABS score. An additional item (ideas of reference) is not included in the total score. Scoring is from 0 (least severe) to 4 (most severe), with total score from 0 to 24.
Time Frame Baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Endpoint
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Participants with Body Dysmorphic Disorder at baseline
Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Psychiatrist's Ratings 15.82  (5.19) 16.91  (4.70)
Psychologist's Ratings 15.91  (6.47) 14.82  (6.46)
5.Secondary Outcome
Title Beck Depression Inventory II
Hide Description The Beck Depression Inventory II (BDI-II) is a 21 item self-report inventory measuring the severity of depression. Individuals are asked to respond to each question based on a two-week time period. Scoring is from 0 (minimal) to 3 (severe), with total score from 0-63. Higher total scores indicate more severe depressive symptoms.
Time Frame Baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Endpoint
Hide Arm/Group Description:
Participants with Body Dysmorphic Disorder at baseline
Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
28.77  (11.49) 22.18  (15.30)
6.Secondary Outcome
Title Beck Anxiety Inventory
Hide Description The Beck Anxiety Inventory (BAI) is a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.
Time Frame Baseline and up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Endpoint
Hide Arm/Group Description:
Participants with Body Dysmorphic Disorder at baseline
Participants with Body Dysmorphic Disorder after Venlafaxine treatment up to 16 weeks
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.90  (8.23) 12.55  (10.86)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Body Dysmorphic Disorder
Hide Arm/Group Description Participants with body dysmorphic disorder
All-Cause Mortality
Body Dysmorphic Disorder
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Body Dysmorphic Disorder
Affected / at Risk (%)
Total   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Body Dysmorphic Disorder
Affected / at Risk (%)
Total   0/17 (0.00%) 
The primary limitations of this study are the small sample size, the open-label design, and the primarily female sample.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Andrea Allen
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-241-3176
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00211809     History of Changes
Other Study ID Numbers: GCO 00-0211PS*
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: January 18, 2017
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017