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Augmentation of (imaginal) exposure therapy with D-cycloserine for patients with Posttraumatic Stress Disorder (PTSD); A Randomized Placebo controlled Study.


- candidate number2972
- NTR NumberNTR1184
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-dec-2007
- Secondary IDsNL1738909107 
- Public TitleAugmentation of (imaginal) exposure therapy with D-cycloserine for patients with Posttraumatic Stress Disorder (PTSD); A Randomized Placebo controlled Study.
- Scientific TitleAugmentation of (imaginal) exposure therapy with D-cycloserine for patients with Posttraumatic Stress Disorder (PTSD); A Randomized Placebo controlled Study.
- ACRONYMN/A
- hypothesisD-cycloserine will improve the effects of exposure therapy.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD)
- Inclusion criteria1. Age between 18 and 65 and;
2. current DSM-IV diagnosis of PTSD established with a structured diagnostic interview (M.I.N.I. and CAPS).
- Exclusion criteria1. Psychosis or delusion disorders (current or in the past);
2. suicidality;
3. mental retardation;
4. substance abuse or dependence or alcohol abuse of dependence, as established by a structured diagnostic interview (M.I.N.I.);
5. pregnant or lactating women. Also women who are planning a pregnancy and don’t want to postpone a pregnancy during the treatment phase are excluded;
6. patients who have a serious and unstable medical illness, as confirmed by their doctor, such as use of a pacemaker, renal disease or porfyrie;
7. a history of epileptic seizures;
8. medication use that may interfere with D-cycloserine, such as anticoagulants;
9. patients who use antidepressants, and are not willing to stop;
10. Patients who use benzodiazepines are included only when they completely stop taking benzodiazepines before the start of the treatment;
11. insufficient ability to speak and write Dutch.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-mrt-2011
- Target number of participants102
- InterventionsExposure therapy with D-cycloserine or placebo.
- Primary outcomePTSD symptoms.
- Secondary outcome1. Depression;
2. anxiety;
3. Posttraumatic Cognitions;
4. avoidance behavior.
- TimepointsPre and posttreatment and follow-ups after 3, 12 en 24 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr A. Minnen, van
- CONTACT for SCIENTIFIC QUERIESProf. dr A. Minnen, van
- Sponsor/Initiator GGZ
- Funding
(Source(s) of Monetary or Material Support)
Achmea Stichting Slachtoffer en samenleving (SASS)
- PublicationsN/A
- Brief summaryThe present study aims at the improvement of exposure therapy for PTSD patients–at this moment the most effective psychotherapeutic treatment programme- by augmentation with D-cycloserine, a newly discovered drug for enhancing learning processes.
- Main changes (audit trail)
- RECORD24-dec-2007 - 17-apr-2008


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