Clinical trial NCT00723060: Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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)

Primary outcomes:
measure: The difference of Y-BOCS score average from baseline to 16-week
timeFrame: baseline and16-week
Secondary outcomes:
measure: 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A
timeFrame: every 2 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul, Korea
name: Jun Soo Kwon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: