Treatment Youth With Obsessive-Compulsive Disorder

NCT00708240 | Unknown Phase 4 DMC

• 1 other identifier: IMHR-REB-2006-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Children's Yale-Brown Obsessive Compulsive Scale score.

  Before and after treatment and at each study visit

Secondary Outcomes (1)

• Clinical Global Impression for Severity of Illness and Improvement

  each study visit

Study Arms (1)

Escitalopram

EXPERIMENTAL

Drug: Escitalopram

Interventions

Escitalopram DRUG

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.

Also known as: Cipralex

Escitalopram

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead
• H. Lundbeck A/S: collaborator

Study Sites (1)

University of Ottawa Institute of Mental Health Research

Ottawa, Ontario, K1Z7K4, Canada

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Martine F. Flament, MD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martine F Flament, MD

CONTACT

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

Metehan Irak, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: July 2, 2008
• Study Start: January 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 2, 2008

Record last verified: 2008-06

Locations

CA (1)