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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 is not yet open for participant recruitment.
Verified by Seoul National University Hospital, July 2008
First Received: July 24, 2008   Last Updated: July 25, 2008   History of Changes
Sponsor: Seoul National University Hospital
Information provided by: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00723060
  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 IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
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 ]

Estimated Enrollment: 166
Arms Assigned Interventions
1: Active Comparator
escitalopram high dose group
Drug: escitalopram
escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)
2: Active Comparator
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

Contacts
Contact: Jun Soo Kwon, M.D., Ph.D. kwonjs@snu.ac.kr

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 ( Seoul National University Hospital )
Study ID Numbers: 11769A
Study First Received: July 24, 2008
Last Updated: July 25, 2008
ClinicalTrials.gov Identifier: NCT00723060     History of Changes
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Dexetimide
Antidepressive Agents, Second-Generation
Obsessive-Compulsive Disorder
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009