Obsessive Compulsive Disorder
Conditions
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). 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
Interventions
DRUGescitalopram
escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of Y-BOCS score average from baseline to 16-week | baseline and16-week |
Secondary
| Measure | Time frame |
|---|---|
| 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A | every 2 week |
Countries
South Korea
Outcome results
None listed