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)

Seoul National University Hospital1 site in 1 country176 target enrollmentSeptember 2008

ConditionsObsessive Compulsive Disorder

Interventionsescitalopram

Drugsescitalopram

Overview

Phase: Phase 4
Intervention: escitalopram
Conditions: Obsessive Compulsive Disorder
Sponsor: Seoul National University Hospital
Enrollment: 176
Locations: 1
Primary Endpoint: The difference of Y-BOCS score average from baseline to 16-week
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

January 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

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)