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Clinical Trials/NCT00723060
NCT00723060CompletedPhase 4

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)

Seoul National University Hospital1 site in 1 country176 target enrollmentStarted: September 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
176
Locations
1
Primary Endpoint
The difference of Y-BOCS score average from baseline to 16-week
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

1

Active Comparator

escitalopram high dose group

Intervention: escitalopram (Drug)

2

Active Comparator

escitalopram conventional group

Intervention: escitalopram (Drug)

Outcomes

Primary Outcomes

The difference of Y-BOCS score average from baseline to 16-week

Time Frame: baseline and16-week

Secondary Outcomes

  • 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A(every 2 week)

Investigators

Sponsor Class
Other

Study Sites (1)

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