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

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)

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

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Drug: escitalopram

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; escitalopram high dose group	Drug: escitalopram; escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)
ACTIVE_COMPARATOR: 2; escitalopram conventional group	Drug: escitalopram; escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jun Soo Kwon, M.D., Ph.D., Seoul National University Hospital, Seoul, Korea

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (ESTIMATE): July 28, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 8, 2011
• Last Update Submitted That Met QC Criteria: August 5, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: 11769A