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Pharmacological enhancement of fear extinction in OCD; a randomized placebo controlled, double blind study.

Pharmacological enhancement of fear extinction in OCD; a randomized placebo controlled, double blind study. - DCS addition in OCD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33819
Enrollment
60
Registered
2009-11-19
Start date
2009-04-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Interventions

Intervention: Half of the subjects will be randomly assigned to the placebo condition and the other half will be randomly Subjects will be randomized to treatment with either placebo, or single fixe

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All patients meet the DSM-IV criteria for OCD - Y-Bocs score: * 18 if obsessions and compulsions; * 12 if only obsessions or compulsions - Male and female, aged between 18-70 years - Female patients of childbearing potential must have a negative pregnancy test and use reliable method of contraception. - Written informed consent - Eligible for exposure therapy

Exclusion criteria

Exclusion criteria: - Presence of any of the following DSM IV conditions: * Major depression (HDRS * 15) * Bipolar Disorder * Schizophrenia or any other psychotic disorder * Tic disorder * Substance related disorder during the past 6 months * Epilepsy or any structural CNS disorder of stroke within the last year;- Presence of primary or co-morbid personality disorder - Evidence of clinically significant and unstable cardiovascular, gastrointestinal, pulmonary, Renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within de past year or micturition abnormalities. - Currently taking benzodiazepines - Patients at risk for suicide - Multiple serious drug allergies of known allergy for DCS - Inability to speak Dutch or English

Design outcomes

Primary

MeasureTime frame
The change in Yale Brown Obsessive Compulsive Scale (Y-BOCS), time of onset of change on the Y-BOCS and time of administering DCS (directly pre- or post ERP).

Secondary

MeasureTime frame
VLGT : Verbal Learning and Memory Test WCST: Wisconsin Card Sorting Test TOL: Tower of London ET: Extinction Task CGI: Clinical Global Impression scale BABS: Brown Assessment of Belief Scale HDRS: Hamilton Depression Rating Scale HARS: Hamilton Anxiety Rating Scale SDS: Sheehan Disability Scales WHOQOL World Health Organization Quality of Life FSEC Fawcett side effects checklist Tic-P: Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)