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

Obsessive Compulsive Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723060
• Other study ID #: 11769A
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2008
• Last updated: August 5, 2011
• Start date: September 2008
• Est. completion date: January 2011

Study information

• Verified date: August 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Drug:
• escitalopram
escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of Y-BOCS score average from baseline to 16-week		baseline and16-week	No
Secondary	1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A		every 2 week	No