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Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder

Primary Purpose

Obsessive Compulsive Disorder

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

escitalopram

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Man or woman, aged 18 to 65 years, outpatient
Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months
Severity: Y-BOCS score of >= 20 at screening and baseline
No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening
Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration.

Exclusion Criteria:

primary active DSM-IV axis I diagnosis other than OCD
History of substance, including alcohol, dependence and psychotic symptoms
Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline
Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity
History of no response to escitalopram or citalopram treatment
History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening
Women who are pregnant, planning to become pregnant, or breast-feeding
Ongoing cognitive behavior therapy (CBT) of OCD
Hoarding or collecting type
Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

escitalopram high dose group

escitalopram conventional group

Outcomes

Primary Outcome Measures

The difference of Y-BOCS score average from baseline to 16-week

Secondary Outcome Measures

1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A

Full Information

NCT ID

NCT00723060

First Posted

July 24, 2008

Last Updated

August 5, 2011

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00723060

Brief Title

Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder

Official Title

Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder (Randomized, Double-blind, Multi-center Study)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

OBJECTIVE: The objective of this study is to compare the effect and safety of conventional dose (20mg) and high dose (40mg) of escitalopram in patients with obsessive-compulsive disorder (OCD). OVERVIEW OF STUDY DESIGN: Prospective, Randomized, Active-controlled, Double-blind, Multi-center, Clinical Trials STUDY POPULATION: Patients with OCD EFFICACY EVALUATIONS: Y-BOCS (D-YBOCS), HAM-D, HAM-A, CGI-S & -I, GAF, OCI-R SAFETY EVALUATION: Adverse Events / Serious Adverse Events, UKU

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

176 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

escitalopram high dose group

Arm Title

Arm Type

Active Comparator

Arm Description

escitalopram conventional group

Intervention Type

Drug

Intervention Name(s)

escitalopram

Intervention Description

escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)

Primary Outcome Measure Information:

Title

The difference of Y-BOCS score average from baseline to 16-week

Time Frame

baseline and16-week

Secondary Outcome Measure Information:

Title

1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A

Time Frame

every 2 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Man or woman, aged 18 to 65 years, outpatient Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months Severity: Y-BOCS score of >= 20 at screening and baseline No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening Drug free period of at least 2 weeks before study drug administration (in case of fluoxetine, at least 5 weeks). However, allowed medications in this study could be taken even before study drug administration. Exclusion Criteria: primary active DSM-IV axis I diagnosis other than OCD History of substance, including alcohol, dependence and psychotic symptoms Current depression A. Risk of suicidal attempt B. 20-item Hamilton Depression Rating Scale (HAM-D)(exclude 21th item, obsession) of >17 at screening or baseline Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity History of no response to escitalopram or citalopram treatment History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening Women who are pregnant, planning to become pregnant, or breast-feeding Ongoing cognitive behavior therapy (CBT) of OCD Hoarding or collecting type Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Soo Kwon, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital, Seoul, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

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Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder

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