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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 December 2018 |
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Main ID: |
EUCTR2008-006947-38-GB |
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Date of registration:
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09/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomised double-blind placebo-controlled pilot study of D-cycloserine-augmented exposure therapy in adolescents with obsessive-compulsive disorder
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Scientific title:
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A randomised double-blind placebo-controlled pilot study of D-cycloserine-augmented exposure therapy in adolescents with obsessive-compulsive disorder |
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Date of first enrolment:
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15/01/2009 |
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Target sample size:
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24 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-006947-38 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
i) DSM-IV diagnosis of OCD
ii) Age 12-18
iii) Referred to the National and Specialist OCD clinic at Maudsley Hospital
iv) If on medication, that should be stable for 12 weeks, and not be changed during the course of the trial
v) Provision of written informed consent (patient and carer)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
i) Current diagnosis of psychosis, current alcohol or substance abuse/dependence
ii) English too poor to engage in treatment
iii) Severe disabling neurological disorder
iv) Medical contraindication to cycloserine, including epilepsy and porphyria
v) A diagnosed global learning disability or pervasive developmental disorder
vi) Characteristics interfering with completion of treatment eg life-threatening or unstable medical illness
vii) Pregnancy
viii) Not suitable for CBT (selective mutism, lack of insight or motivation to change)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Obsessive-compulsive disorder (OCD)
MedDRA version: 9.1
Level: LLT
Classification code 10029898
Term: Obsessive-compulsive disorder
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Intervention(s)
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Trade Name: Cycloserine
Pharmaceutical Form: Capsule*
Other descriptive name: D-cycloserine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: To establish the clinical effectiveness of D-cycloserine (DCS) augmented cognitive behavioural therapy (CBT) for children and adolescents with OCD, and whether that affects the speed of recovery.
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Primary end point(s): Childrens' Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
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Secondary Objective: To determine which processes in fear extinction are modified by DCS, and when this occurs, during exposure therapy for OCD in young people.
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Secondary ID(s)
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RAA2008-014
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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