Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
Seoul National University Hospital Identifier:
First received: July 24, 2008
Last updated: August 5, 2011
Last verified: August 2011

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

Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: escitalopram
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The difference of Y-BOCS score average from baseline to 16-week [ Time Frame: baseline and16-week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A [ Time Frame: every 2 week ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: September 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00723060

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Jun Soo Kwon, M.D., Ph.D. Seoul National University Hospital, Seoul, Korea
  More Information

Responsible Party: Seoul National University Hospital Identifier: NCT00723060     History of Changes
Other Study ID Numbers: 11769A 
Study First Received: July 24, 2008
Last Updated: August 5, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents processed this record on October 21, 2016