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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00723060
First received: July 24, 2008
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

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:

U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723060

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

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov 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:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 23, 2013