Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 468 for:    ESCITALOPRAM AND Cholinergic

Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder

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.
 
ClinicalTrials.gov Identifier: NCT00149799
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : November 21, 2014
Last Update Posted : December 5, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Rhode Island Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital

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
Enrollment 100
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Phase I: Open-Label Escitalopram Phase II: Double-blind Escitalopram Phase II: Double-blind Placebo
Hide Arm/Group Description 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. 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. 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.
Period Title: Open Label Escitalopram (Phase I)
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 Title: Discontinuation (Phase II)
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
Arm/Group Title Phase II: Escitalopram Phase II: Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
37.3  (12.4) 31.8  (13.5) 33.5  (12.4)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
20
  71.4%
20
  66.7%
40
  69.0%
Male
8
  28.6%
10
  33.3%
18
  31.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 30 participants 58 participants
28 30 58
1.Primary Outcome
Title Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
Hide Description We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
Time Frame Phase II: Biweekly for six months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis of all 58 patients randomized to Phase II.
Arm/Group Title Phase II: Escitalopram Phase II: Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 28 30
Measure Type: Number
Unit of Measure: percentage of subjects who relapsed
18 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Escitalopram, Phase II: Placebo
Comments Cox proportional hazards regression was used to compare relapse rates (accounting for censoring and time from randomization to relapse) in Phase II.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Regression, Cox
Comments p-value is based on the likelihood ratio Chi-Square statistic.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.73
Confidence Interval (2-Sided) 95%
1.01 to 8.59
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
Hide Description We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.
Time Frame Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I: Open-Label Escitalopram
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of subjects who responded
67
3.Secondary Outcome
Title Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Hide Description Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.
Time Frame Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 58 participants who had responded to open-label Escitalopram (phase 1) were randomized to receive either Escitalopram (n=28) or placebo (n=30) in the double-blind relapse prevent trial (phase 2). Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
Arm/Group Title Phase II: Escitalopram Phase II: Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 28 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 14 Number Analyzed 28 participants 29 participants
3.5357143  (4.4010280) 3.3793103  (3.3744184)
Week 16 Number Analyzed 28 participants 30 participants
3.8928571  (4.1840906) 4.2333333  (3.9799786)
Week 18 Number Analyzed 28 participants 27 participants
5.2857143  (5.5099717) 6.3703704  (6.4875511)
Week 20 Number Analyzed 26 participants 28 participants
4.8461538  (5.5403416) 5.4285714  (4.7798076)
Week 22 Number Analyzed 26 participants 27 participants
4.2307692  (3.5922995) 3.7407407  (3.0457106)
Week 24 Number Analyzed 25 participants 23 participants
3.625  (3.3337862) 3.7727273  (3.0539875)
Week 26 Number Analyzed 24 participants 25 participants
3.8695652  (4.0486176) 4.04  (3.8457769)
Week 28 Number Analyzed 25 participants 23 participants
4.48  (5.0259327) 4.4090909  (3.4731499)
Week 30 Number Analyzed 23 participants 23 participants
2.85  (3.9373381) 4.5454545  (4.0676104)
Week 32 Number Analyzed 23 participants 22 participants
2.9565217  (3.067102) 4.2  (4.007887)
Week 34 Number Analyzed 25 participants 21 participants
3.375  (3.2412088) 4.7  (4.5664682)
Week 36 Number Analyzed 25 participants 22 participants
4.0416667  (3.9943348) 5.4  (5.2555735)
Week 38 Number Analyzed 23 participants 15 participants
3.8181818  (3.8623502) 3.4666667  (3.8705235)
Week 40 Number Analyzed 25 participants 19 participants
4.2400000  (4.8500859) 4.1578947  (5.0250833)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Escitalopram, Phase II: Placebo
Comments

We compared change in depression over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.

Null hypothesis: The rate of change in depression symptom severity in the Escitalopram group will not be significantly different from the placebo group [to be tested].

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0930
Comments A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)
Method Mixed Models Analysis
Comments Degrees of freedom=556
Method of Estimation Estimation Parameter Slope difference
Estimated Value -0.07006
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04163
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Hide Description Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.
Time Frame Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)
Hide Outcome Measure Data
Hide Analysis Population Description
28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.
Arm/Group Title Phase II: Escitalopram Phase II: Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 28 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 14 Number Analyzed 28 participants 29 participants
9.0000000  (2.6943013) 8.2413793  (2.3551641)
Week 28 Number Analyzed 25 participants 23 participants
9.8000000  (3.3040379) 9.0000000  (2.7961012)
Week 40 Number Analyzed 25 participants 19 participants
9.7600000  (3.6887215) 8.8947368  (3.1428002)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Escitalopram, Phase II: Placebo
Comments

We compared change in functional impairment over time during trial phase 2 by treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.

Null hypothesis: The rate of change in functional impairment in the Escitalopram group will not be significantly different from that of the placebo group [to be tested].

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9766
Comments A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)
Method Mixed Models Analysis
Comments Degrees of freedom=43
Method of Estimation Estimation Parameter Slope difference
Estimated Value 0.001176
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.03991
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Hide Description Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.
Time Frame Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)
Hide Outcome Measure Data
Hide Analysis Population Description
28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.
Arm/Group Title Phase II: Escitalopram Phase II: Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 28 30
Mean (Standard Deviation)
Unit of Measure: Percentage score
Week 14 Number Analyzed 28 participants 27 participants
74.1785714  (12.9930282) 70.9259259  (16.0166402)
Week 28 Number Analyzed 22 participants 19 participants
70.2727273  (14.1528453) 67.3684211  (16.0665648)
Week 40 Number Analyzed 24 participants 17 participants
69.0833333  (18.5376624) 68.6470588  (15.2436100)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Phase II: Escitalopram, Phase II: Placebo
Comments

We compared change in Q-LES-Q-SF percent scores over time by randomized treatment group (Escitalopram vs. Placebo) using a random coefficient model that included terms for treatment group, time, site, and all their interactions, modeling intercepts and slopes as random effects per person.

Null hypothesis: The rate of change in Q-LES-Q-SF percent scores in the Escitalopram group will not be significantly different from that of the placebo group [to be tested].

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7724
Comments A priori threshold for statistical significance: 0.0167 Model term of interest: treatment by time interaction (i.e., slope difference between treatments over time)
Method Mixed Models Analysis
Comments Degrees of freedom=36
Method of Estimation Estimation Parameter Slope difference
Estimated Value 0.05723
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.1963
Estimation Comments [Not Specified]
Time Frame Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: Open-Label Escitalopram Phase II: Escitalopram Phase II: Placebo
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Phase I: Open-Label Escitalopram Phase II: Escitalopram Phase II: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Open-Label Escitalopram Phase II: Escitalopram Phase II: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/100 (0.00%)      0/28 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: Open-Label Escitalopram Phase II: Escitalopram Phase II: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/100 (89.00%)      22/28 (78.57%)      21/30 (70.00%)    
Cardiac disorders       
Heart Palpitations   2/100 (2.00%)  2 1/28 (3.57%)  2 2/30 (6.67%)  2
Endocrine disorders       
Hot Flashes   0/100 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  2
Gastrointestinal disorders       
Nausea   36/100 (36.00%)  43 3/28 (10.71%)  4 4/30 (13.33%)  4
Flatulence   10/100 (10.00%)  10 2/28 (7.14%)  4 1/30 (3.33%)  1
Diarrhea   10/100 (10.00%)  11 5/28 (17.86%)  9 0/30 (0.00%)  0
Abdominal Pain   7/100 (7.00%)  7 2/28 (7.14%)  2 1/30 (3.33%)  1
Indigestion   4/100 (4.00%)  5 2/28 (7.14%)  2 0/30 (0.00%)  0
Vomiting   1/100 (1.00%)  1 2/28 (7.14%)  3 0/30 (0.00%)  0
General disorders       
Fatigue   42/100 (42.00%)  55 6/28 (21.43%)  7 4/30 (13.33%)  4
Dry Mouth   28/100 (28.00%)  30 1/28 (3.57%)  1 3/30 (10.00%)  3
Headache   41/100 (41.00%)  58 9/28 (32.14%)  18 9/30 (30.00%)  16
Dizziness   6/100 (6.00%)  6 1/28 (3.57%)  1 6/30 (20.00%)  6
Sweating   8/100 (8.00%)  11 1/28 (3.57%)  1 1/30 (3.33%)  1
Vivid Dreams   5/100 (5.00%)  5 2/28 (7.14%)  2 0/30 (0.00%)  0
Yawning   5/100 (5.00%)  5 0/28 (0.00%)  0 2/30 (6.67%)  2
Restless Sleep / Not Insomnia   0/100 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  2
Metabolism and nutrition disorders       
Change in Appetite   23/100 (23.00%)  25 1/28 (3.57%)  1 3/30 (10.00%)  3
Musculoskeletal and connective tissue disorders       
Back Pain   2/100 (2.00%)  2 0/28 (0.00%)  0 2/30 (6.67%)  2
Psychiatric disorders       
Insomnia   34/100 (34.00%)  37 3/28 (10.71%)  4 7/30 (23.33%)  7
Agitation   12/100 (12.00%)  13 0/28 (0.00%)  0 1/30 (3.33%)  2
Irritability   6/100 (6.00%)  6 2/28 (7.14%)  2 4/30 (13.33%)  4
Somnolence   8/100 (8.00%)  9 0/28 (0.00%)  0 1/30 (3.33%)  1
Anxiety   6/100 (6.00%)  9 1/28 (3.57%)  1 2/30 (6.67%)  2
Reproductive system and breast disorders       
Sexual Dysfunction   31/100 (31.00%)  33 2/28 (7.14%)  2 1/30 (3.33%)  1
Menstrual Cramps   3/100 (3.00%)  4 2/28 (7.14%)  2 1/30 (3.33%)  1
Respiratory, thoracic and mediastinal disorders       
Cold Symptoms   7/100 (7.00%)  10 4/28 (14.29%)  6 3/30 (10.00%)  4
Rhinitis   1/100 (1.00%)  1 2/28 (7.14%)  2 0/30 (0.00%)  0
Upper Respiratory Infection   0/100 (0.00%)  0 2/28 (7.14%)  2 0/30 (0.00%)  0
Skin and subcutaneous tissue disorders       
Poison Ivy   0/100 (0.00%)  0 0/28 (0.00%)  0 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
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.
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: Katharine A. Phillips, MD
Organization: Rhode Island Hospital
Phone: 401-444-1646
EMail: katharine_phillips@brown.edu
Layout table for additonal information
Responsible Party: Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00149799     History of Changes
Other Study ID Numbers: R01MH072854 ( U.S. NIH Grant/Contract )
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