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Trial record 51 of 582 for:    ESCITALOPRAM

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

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ClinicalTrials.gov Identifier: NCT00215137
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : October 29, 2013
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition OCD
Interventions Drug: escitalopram
Drug: Placebo ( sugar pill)
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Escitalopram Randomization Placebo Randomization Escitalopram
Hide Arm/Group Description Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
Period Title: Open Label Escitalopram
Started 14 0 0
Completed 13 0 0
Not Completed 1 0 0
Reason Not Completed
Lack of Efficacy             1             0             0
Period Title: Randomization Period
Started 0 7 5
Completed 0 5 5
Not Completed 0 2 0
Reason Not Completed
Lost to Follow-up             0             1             0
Withdrawal by Subject             0             1             0
Arm/Group Title Open Label Escitalopram
Hide Arm/Group Description Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
Only the open label treatment phase is being reported per reviewer's instructions. The other arms are for the second phase of the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
39.14  (13.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
9
  64.3%
Male
5
  35.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale
Hide Description The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty.
Time Frame Open Label Phase Baseline,Randomization Phase Baseline or Beginning
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Escitalopram Randomization Placebo Randomization Escitalopram
Hide Arm/Group Description:
Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample.
Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample.
Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample.
Overall Number of Participants Analyzed 14 7 5
Mean (Standard Deviation)
Unit of Measure: units on a scale
Beginning of Study Phase 24.79  (4.48) 12.71  (6.13) 16.00  (6.96)
End of Study Phase 15.36  (7) 20.17  (11.57) 15.8  (7.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Label Escitalopram
Comments A Wilcoxon Signed Rank test was performed on the difference between the open label endpoint and baseline YBOCS scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Randomization Placebo, Randomization Escitalopram
Comments A Wilcoxon Rank Sum Test was performed on the difference in the pre and post randomization YBOCS scores, using grouping to either escitalopram or placebo as a grouping variable.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0417
Comments [Not Specified]
Method Wilcoxon Rank Sum Test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Escitalopram Randomization Placebo Randomization Escitalopram
Hide Arm/Group Description Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects. Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7). Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
All-Cause Mortality
Open Label Escitalopram Randomization Placebo Randomization Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Escitalopram Randomization Placebo Randomization Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/7 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Open Label Escitalopram Randomization Placebo Randomization Escitalopram
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/7 (0.00%)   0/5 (0.00%) 
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: Wei Zhang MD
Organization: Duke University Medical Center Dept of Psychiatry
Phone: 919 684 5645
Publications of Results:
C. Joseph Wang, M.D., Ph.D.; Jonathan R. Davidson, M.D.; Kathryn M. Connor, M.D.;Weihui Li1, M.D.,Ph.D. and Wei Zhang, M.D., Ph.D. Unpublished Manuscript
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00215137     History of Changes
Other Study ID Numbers: Pro00013150
5731-04-4R0 ( Other Identifier: Duke legacy protocol number )
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: April 15, 2013
Results First Posted: October 29, 2013
Last Update Posted: July 23, 2014