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
ClinicalTrials.gov Identifier:
NCT00723060
First Posted: July 28, 2008
Last Update Posted: August 8, 2011
Information provided by:
Seoul National University Hospital
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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 (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
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | July 24, 2008 |
| First Posted: | July 28, 2008 |
| Last Update Posted: | August 8, 2011 |
| Last Verified: | August 2011 |
Additional relevant MeSH terms:
|
Disease Compulsive Personality Disorder Obsessive-Compulsive Disorder Pathologic Processes Personality Disorders Mental Disorders Anxiety Disorders 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 |