treatment outcome in OCD. Objective: The objective for this study is fourfold. First we will determine whether DCS addition to behavioural exposure therapy may enhance fear extinction and improve symptoms in OCD. Our hypothesis is that improvement…
ID
Source
Brief title
Condition
- Psychiatric disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Obsessive Compulsive Disorder (OCD) is a chronic and severe psychiatric
disorder which affects 2-3% of the general population. The use of medication
for OCD is very common, but often less effective without psychotherapy.
Behavioural therapy (Exposure and Response prevention) is currently the
treatment of choice for OCD and aims to help patients changing their
behaviours. Notwithstanding effective treatment 40-60 % of OCD patients fail to
respond to behavioural exposure therapy. Procedurally, exposure is based on
extinction of conditioned fear. Recent work in rodents and humans has
demonstrated that acute treatment with D-cycloserine (DCS) a partial agonist of
the NMDA-receptor enhances the learning and memory processes underlying
extinction of fear. Adding DCS to exposure therapy might improve treatment
outcome in OCD and at a faster rate.
Study objective
treatment outcome in OCD.
Objective: The objective for this study is fourfold. First we will determine
whether DCS addition to behavioural exposure therapy may enhance fear
extinction and improve symptoms in OCD. Our hypothesis is that improvement will
occur and at a faster rate than with no addition of DCS. Additionally we aim to
establish the optimal timing of administration of D-Cycloserine (directly pre-
or post ERP). Furthermore, we will examine the underlying pathophysiologic
mechanisms of fear extinction in OCD with neuro-imaging studies. The brain
activity of the amygdale and cortico-striatal circuits will be assessed in
fifty patients before and after behavioural exposure treatment and DCS by means
of functional magnetic resonance imaging (fMRI) in a fear extinction paradigm.
In addition, we will examine the fear extinction enhancement of DCS using a
neuropsychological paradigm. We hypothesize based on rodent and limited human
studies that DCS is a performance enhancer in different learning, memory and
executive tasks. Finally, from a health economic perspective the question is
whether the benefits of treatment only lead to an increased efficiency (less
therapy sessions and thus costs for similar health outcomes),or better health
outcomes for the same short term costs (therapy sessions). Thereby faster
and/or better response could also reduce indirect costs (generated by lost
productivity in paid work).
Study design
A randomized, double blind, placebo-controlled fixed dose study.
Intervention
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 fixed dosages of 125mg in 1 of 3
possible conditions. Patients in condition 1 will receive DCS before and
placebo after exposure sessions. Patients in condition 2 will receive Placebo
both before and after exposure sessions. Patients in condition 3 will receive
placebo before and DCS after exposure sessions.
Study burden and risks
Side-effects of D-Cycloserine are limited, since study dosing is low (125 mg).
Exept for this small chance on side effects, there are no serious risks
associated to this study. Advantages to the subjects can be expected because of
the potential therapeutic effect (faster reduction in OCD-symptoms and lower
drop-out rates). Futhermore, the results can offer insight into the
pathofysiology of OCD and may lead to future development of more effective
treatmentmethods.
Meibergdreef 5
1105 AZ
NL
Meibergdreef 5
1105 AZ
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2009-010919-32-NL |
CCMO | NL24096.018.09 |