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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:
Seoul National University Hospital
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
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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 (Participant, 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 ]
Secondary Outcome Measures:
- 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A [ Time Frame: every 2 week ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00723060
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 |
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 June 28, 2017