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Completed

NCT Number: NCT00723060

Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Escitalopram

Drug

escitalopram high dose group (40mg) escitalopram conventional dose group (20mg)

Primary outcomes

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

    Time frame: baseline and16-week

Secondary outcomes

  1. 1) CGI-S, CGI-I 2) GAF 3) HAM-D, HAM-A

    Time frame: every 2 week

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2008
Registry last updated
Aug 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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