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

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:	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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

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:

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.

Exclusion Criteria:

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)

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 February 12, 2012