The aim of this pilot-study is to establish the potential efficacy of acute doses of 50 mgs D-cycloserine (DCS), a partial NMDA agonist, in accelerating and/or augmenting the effect of exposure and response prevention (ERP) in the treatment of…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of OCD symptoms as measured by the YBOCS during and directly
afterwards the structured ERP treatment and 1 month and 3 months later.
Secondary outcome
Assessments of the rate of anxiety and avoidance related to specific target
symptoms.
Also the CGI and the PADUA-R will be done.
Response percentages (defined as minimal 30% reduction on the Y-BOCS) will be
compared.
Background summary
Obsessive-compulsive disorder (OCD) is a disabling disorder with a prevalence
of about 1%. Exposure and response prevention (ERP) is an evidence-based
treatment for patients with OCD. Extinction of conditioned anxiety is a key
element of this treatment method. Althought ERP is effective in OCD, treatment
effects are fairly often rather limited or absent. So there is a need for new
means and/or methods in order to enhance the effects of ERP. In animal studies
it has been shown that extinction of conditioned anxiety is enhanced by acute
doses of D-cycloserine (DCS) in combination with exposure. Two clinical studies
concerning patients with acrophobia and social anxiety, have shown that
addition of DCS to exposure sessions improved treatment results.
Study objective
The aim of this pilot-study is to establish the potential efficacy of acute
doses of 50 mgs D-cycloserine (DCS), a partial NMDA agonist, in accelerating
and/or augmenting the effect of exposure and response prevention (ERP) in the
treatment of obsessive-compulsive disorder (OCD).
Study design
A randomised, dubble-blind, placebo controlled study design. It is a parallel
design with two arms.
Intervention
Both groups will receive a series of 6 (plus one introductioin session)
structured exposure and response prevention sessions. One group will take
capsules with 50 mgs of DCS prior to each treatment session, the other group
will get capsules with placebo.
After this structured treatment phase patients will receive further CGT without
addition of DCS/placebo. In this phase further treatment effects will be
assessed.
Study burden and risks
De belasting bestaat vooral uit extra tijdsinvestering van de patiënt i.v.m.
vragenlijstafnames en 'wachttijd' vanwege het feit dat de capsule DCS/placebo
een uur voorafgaand aan de behandelsessies wordt ingenomen.
In de gebruikte dosering is de kans op bijwerkingen minimaal.
The burden for patients consists mainly of extra investments of time for
interviews and rating scales, and 'waiting time' when patients receive the
capsules one hour before starting the ERP sessions.
With the acute doses used in this study the risks of adverse events are
minimal.
Veldwijk 75
3853 LC Ermelo
NL
Veldwijk 75
3853 LC Ermelo
NL
Listed location countries
Age
Inclusion criteria
- Patients with a primary DSM-IV diagnosis of OCD with an age of 18 years and older as established with the Structural Clinical Interview for axis I DSM-IV Disorders (SCID I)
- Obsessive-compulsive complaints has to be such that exposure in vivo is feasible at the outpatient department, in the clinic or the direct environment.
- Patients have to understand the rationale of exposure therapy and there has to be a readiness to participate in exposure sessions.
- If a patient uses medication, dosages have to be stable (no changes in the last 2 months and during the study period).
- Negative pregnancy test (β-HCG in urine).
Exclusion criteria
- Addiction to alcohol or drugs or abuse of these compounds
- A primary diagnosis of a personality disorder
- Psychotic disorder
- Relevant somatic disorders
- Suicidal intentions
- Pregnancy or breastfeeding
- Usage of medication possibly interfering with DCS (isoniazide, protonionamide)
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 | EUCTR2007-000367-18-NL |
| CCMO | NL15991.097.07 |