E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Posttraumatic stress disorder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036876 |
E.1.2 | Term | Prolonged posttraumatic stress disorder |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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). |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |