Recruiting

Obsessive-Compulsive Disorder

Sponsor:

University of Ottawa

Code:

NCT00708240

Conditions

Obsessive Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Accepted

Interventions

Escitalopram

Study Details

Brief summary:

Although research suggests that patients with obsessive-compulsive disorder (OCD) exhibit specific deficits in their high cognitive processes, it is still unknown how these deficits relate to the clinical symptoms of the disorder, and to the response to treatment. There are two aims for the proposed research. The first is to examine how high cognitive processes and brain activity are affected in OCD. The second aim is to investigate the effects of a specific psychotropic medication (escitalopram) on high cognitive processes and brain activity in OCD. We will investigate how 40 youth with OCD (recruited in specialized clinics) differ from 40 healthy youth (recruited from the local community) on selected cognitive tests and brain imaging paradigms, as well as explore how treatment with medication can correct or reverse the observed differences. The final goal of our research is to learn more about the mechanisms of action for available treatments, in order to refine and improve short- and long-term therapeutic strategies for a highly debilitating and often lifelong disorder.

Conditions

Obsessive Compulsive Disorder

Study ID

NCT00708240

Start date

Jan, 2007

Status verified date

Jun, 2008

Completion date

Dec, 2010

Anticipated

Primary completion date

Aug, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 19

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Be 13 to 19 years old
  • Have at least average intellectual ability
  • Currently meet DSM-IV-TR criteria for OCD, upon completion of the Anxiety Disorder Interview Schedule for DSM-IV - Research and Lifetime Version for child and parent (ADIS- RLV)
  • Receive a total score equal to or greater than 20 on the CY-BOCS at the screening visit have less than 25% decrease on the CY-BOCS total score between the screening and baseline visit
  • If female of childbearing potential and sexually active in a heterosexual relationship, the subject must be using a reliable method of contraception, such as hormonal contraceptives
  • Oral contraceptives must have been started at least 3 months prior to the start of the study

Exclusion Criteria:

  • Clinically significant and/or unstable medical condition, including cardiovascular, respiratory, hematological, neurological and endocrine diseases
  • History of neurological disorder or head injury
  • Current use of medication with central nervous system effects
  • Substance abuse or dependence within 6 months prior to enrolment
  • Contra-indication to the fMRI
  • Color blindness
  • A comorbid current DSM-IV Axis I diagnosis, except for tic disorders and another anxiety disorder, as long as the associated disorder is less disabling than the primary diagnosis of OCD, as can be assessed with the ADIS
  • Patients who would require additional psychological or pharmacological treatment
  • Significant suicide risk, based on clinical judgment and the relevant section of the ADIS
  • Hypersensitivity to escitalopram
  • Previous non-response to an adequate trial of escitalopram
  • Any lifetime psychiatric disorder as assessed on the ADIS
  • A lifetime diagnosis of schizophrenia in biological parents or siblings

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Escitalopram

Interventions

Escitalopram

Escitalopram will be provided in unit doses commercially available, with a starting dose, minimum effective dose, and maximum effective dose of 5 mg, 10 mg and 20 mg, respectively, given once daily.

Primary outcome measure

  • Children's Yale-Brown Obsessive Compulsive Scale score. [ Time Frame: Before and after treatment and at each study visit ]

Central Contacts and Locations

Central contacts

Martine F Flament, MD

613-722-6521martine.flament@rohcg.on.ca

Metehan Irak, PhD

613-722-6521metehan.irak@rohcg.on.ca

Locations

University of Ottawa Institute of Mental Health Research

Recruiting

Ottawa, Ontario, Canada, K1Z7K4

Contacts

Zul Merali, PhD

613-722-6521zul.merali@rohcg.on.ca

Principal Investigator:

Martine F. Flament, MD

More Information

Sponsor

University of Ottawa

Last update posted

Jul 2, 2008

Last verified

Jun, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2008-07-02.