Posttraumatic stress disorder MedDRA version: 9.1 Level: LLT Classification code 10036876 Term: Prolonged posttraumatic stress disorder
Conditions
Interventions
Product Name: D-cycloserine
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
GGZ Nijmegen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are (1) 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diagnostic exclusion criteria are (1) 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.). Medical exclusion criteria are (1) 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. According to the Informatorium Medicamentorum (2006), the influence of the use of D-cycloserine during pregnancy and breastfeeding is unknown. However, for safety reasons, we exclude these women. (2) patients who have a serious and unstable medical illness, as confirmed by their doctor, such as use of a pacemaker, renal disease or porfyrie (3) a history of epileptic seizures (4) medication use that may interfere with D-cycloserine, such as anticoagulants (5) patients who use antidepressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present study aims at the improvement of exposure therapy –at this moment the most effective psychotherapeutic treatment programme for posttraumatic stress disorder - by augmentation with D-cycloserine, a newly discovered drug for enhancing learning processes. ;Secondary Objective: ;Primary end point(s): PTSD symptoms | — |
Countries
Netherlands
Outcome results
None listed