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

Study Overview
=================
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

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)

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: escitalopram


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>escitalopram high dose group | Drug: escitalopram<br>* escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)<br>|
| Active Comparator: 2<br>escitalopram conventional group | Drug: escitalopram<br>* escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of Y-BOCS score average from baseline to 16-week |  | baseline and16-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A |  | every 2 week |