Onderzoek naar het effect van de toevoeging van D-cycloserine aan exposure sessies bij de behandeling van patiënten met een obsessieve-compulsieve stoornis.

The effect of the addition of D-cycloserine to exposure sessions in the treatment of patients with obsessive-compulsive disorder. A randomized, placebo-controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27916

Enrollment

Registered

2008-01-17

Start date

2008-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Obsessive-compulsive disorder (NLD: Obsessieve-compulsieve stoornis).

Interventions

Acute doses of 125 mg D-cylcoserine or placebo 1 hour before 6 weekly exposure sessions.

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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); 2. Obsessive-compulsive complaints has to be such that exposure in vivo is feasible at the outpatient department, in the clinic or the direct environment; 3. Patients have to understand the rationale of exposure therapy and there has to be a readiness to participate in exposure sessions; 4. If a patient uses medication, dosages have to be stable (no changes in the last 2 months and during the study period); 5. Negative pregnancy test (â-HCG in urine).

Exclusion criteria

Exclusion criteria: 1. Addiction to alcohol or drugs or abuse of these compounds; 2. A primary diagnosis of a personality disorder; 3. Psychotic disorder; 4. Relevant somatic disorders; 5. Suicidal intentions; 6. Pregnancy or breastfeeding; 7. Usage of medication possibly interfering with DCS (isoniazide, protonionamide).

Design outcomes

Primary

Measure	Time frame
The differences in scores on the Y-BOCS (clinical interview) between baseline and half-way and afterwards the series of ERP sessions will be taken as the primary outcome measure. The mean scores of the two groups (placebo vs. DCS) at these time points will be compared and analyzed. One and three months after the scheduled ERP sessions, when patients may have received further regular CBT, the Y-BOCS will be done again and it can be determined if acceleration of effect results in better outcome at follow up.	—

Measure

Time frame

The differences in scores on the Y-BOCS (clinical interview) between baseline and half-way and afterwards the series of ERP sessions will be taken as the primary outcome measure. The mean scores of the two groups (placebo vs. DCS) at these time points will be compared and analyzed. One and three months after the scheduled ERP sessions, when patients may have received further regular CBT, the Y-BOCS will be done again and it can be determined if acceleration of effect results in better outcome at follow up.

—

Secondary

Measure	Time frame
1. Assessments of the rate of anxiety and avoidance related to specific target symptoms; 2. CGI and the PADUA-R; 3. Response percentages (defined as minimal 30% reduction on the Y-BOCS) will be compared.	—

Contacts

Public ContactA.S. Leeuw, de

Meerkanten GGZ Postbus 1000

aleeuw@meerkanten.nl0341-566680

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)