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

NCT00723060 | Completed Phase 4 DMC

• 1 other identifier: 11769A
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The difference of Y-BOCS score average from baseline to 16-week

  baseline and16-week

Secondary Outcomes (1)

• 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A

  every 2 week

Study Arms (2)

1

ACTIVE COMPARATOR

escitalopram high dose group

Drug: escitalopram

2

ACTIVE COMPARATOR

escitalopram conventional group

Drug: escitalopram

Interventions

escitalopram DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jun Soo Kwon, M.D., Ph.D.

  Seoul National University Hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2008
• First Posted: July 28, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2011-08

Locations

KR (1)