Een gerandomiseerde placebo gecontroleerde studie naar de toegevoegde waarde van D-cycloserine aan exposure therapie bij patiënten met een poststraumatische stress stoornis

• Conditions: Posttraumatic stress disorder; MedDRA version: 9.1Level: LLTClassification code 10036876Term: Prolonged posttraumatic stress disorder

• Registration Number: EUCTR2007-003891-20-NL
• Lead Sponsor: GGZ Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-23
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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