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

NCT ID: NCT00723060

Last Updated: 2011-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-01-31

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

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

escitalopram high dose group

Group Type: ACTIVE_COMPARATOR

escitalopram

Intervention Type: DRUG

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

2

escitalopram conventional group

Group Type: ACTIVE_COMPARATOR

escitalopram

Intervention Type: DRUG

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

Interventions

escitalopram

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Man or woman, aged 18 to 65 years, outpatient

2. Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six months

3. Severity: Y-BOCS score of >= 20 at screening and baseline

4. No history or evidences of clinically significant physical problem, or abnormal laboratory findings at screening

5. 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

1. primary active DSM-IV axis I diagnosis other than OCD

2. History of substance, including alcohol, dependence and psychotic symptoms

3. 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

4. Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram B. History of severe drug allergic reactions or hypersensitivity

5. History of no response to escitalopram or citalopram treatment

6. History of electroconvulsive therapy or received an injectable antipsychotic formulation within 6 months before screening

7. Women who are pregnant, planning to become pregnant, or breast-feeding

8. Ongoing cognitive behavior therapy (CBT) of OCD

9. Hoarding or collecting type

10. Unable to perform study protocol as clinically assessed by the investigator (ex, severe personality disorder)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Seoul, Korea

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

11769A

Identifier Type: -

Identifier Source: org_study_id