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

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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Citalopram hydrobromide Citalopram 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 (Adult)
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

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 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


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:


Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Compulsive Behavior Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders Impulsive Behavior Citalopram Dexetimide 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 Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents

ClinicalTrials.gov processed this record on September 30, 2016