Status:
COMPLETED
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder
Lead Sponsor:
Seoul National University Hospital
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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). OVERV...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00723060
Start Date
September 1 2008
End Date
January 1 2011
Last Update
August 8 2011
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744