Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-Compulsive Disorder
Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive Compulsive Disorder
Intervention: escitalopram (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s):
Jun Soo Kwon, M.D., Ph.D., Principal Investigator, Affiliation: Seoul National University Hospital, Seoul, Korea
Overall contact:
Jun Soo Kwon, M.D., Ph.D., Email: kwonjs@snu.ac.kr
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).
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
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: The difference of Y-BOCS score average from baseline to 16-week
Secondary outcome: 1) CGI-S, CGI-I
2) GAF
3) HAM-D, HAM-A
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Man or woman, aged 18 to 65 years, outpatient
2. Primary OCD patients diagnosed with DSM-IV-TR, having OCD symptoms for more than six
months
3. Severity: Y-BOCS score of >= 20 at screening and baseline
4. No history or evidences of clinically significant physical problem, or abnormal
laboratory findings at screening
5. 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:
1. primary active DSM-IV axis I diagnosis other than OCD
2. History of substance, including alcohol, dependence and psychotic symptoms
3. 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
4. Drug allergy A. Known or suspected hypersensitivity to escitalopram or citalopram
B. History of severe drug allergic reactions or hypersensitivity
5. History of no response to escitalopram or citalopram treatment
6. History of electroconvulsive therapy or received an injectable antipsychotic
formulation within 6 months before screening
7. Women who are pregnant, planning to become pregnant, or breast-feeding
8. Ongoing cognitive behavior therapy (CBT) of OCD
9. Hoarding or collecting type
10. Unable to perform study protocol as clinically assessed by the investigator (ex,
severe personality disorder)
Locations and Contacts
Jun Soo Kwon, M.D., Ph.D., Email: kwonjs@snu.ac.kr
Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information
Last updated: July 25, 2008
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