Trial Outcomes & Findings for Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder (NCT NCT00215137)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Open Label Phase Baseline,Randomization Phase Baseline or Beginning

Results posted on

2014-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Escitalopram 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.	Randomization Placebo 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).	Randomization Escitalopram 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).
Open Label Escitalopram STARTED	14	0	0
Open Label Escitalopram COMPLETED	13	0	0
Open Label Escitalopram NOT COMPLETED	1	0	0
Randomization Period STARTED	0	7	5
Randomization Period COMPLETED	0	5	5
Randomization Period NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Escitalopram 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.	Randomization Placebo 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).
Open Label Escitalopram Lack of Efficacy	1	0
Randomization Period Lost to Follow-up	0	1
Randomization Period Withdrawal by Subject	0	1

Baseline Characteristics

Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Escitalopram n=14 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.14 years STANDARD_DEVIATION 13.27 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Open Label Phase Baseline,Randomization Phase Baseline or Beginning

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.

Outcome measures

Outcome measures
Measure	Open Label Escitalopram n=14 Participants 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.	Randomization Placebo n=7 Participants 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.	Randomization Escitalopram n=5 Participants 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.
Yale Brown Obsessive Compulsive Scale Beginning of Study Phase	24.79 units on a scale Standard Deviation 4.48	12.71 units on a scale Standard Deviation 6.13	16.00 units on a scale Standard Deviation 6.96
Yale Brown Obsessive Compulsive Scale End of Study Phase	15.36 units on a scale Standard Deviation 7	20.17 units on a scale Standard Deviation 11.57	15.8 units on a scale Standard Deviation 7.79

Adverse Events

Open Label Escitalopram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomization Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomization Escitalopram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wei Zhang MD

Duke University Medical Center Dept of Psychiatry

Phone: 919 684 5645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place