A new treatment for combat-related traumatic experiences.

Phase 1

• Conditions: Post-traumatic stress disorder.; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-000934-16-NL
• Lead Sponsor: TNO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-15
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

- aged between 18 and 65 years;
- a primary diagnosis of PTSD according to DSM-5, resulting from combat-related trauma(s);
- a score of > 20 on the Posttraumatic Symptom Scale at screening.
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 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- other relevant treatment for PTSD within 3 months before start of the study;
- start of new medication within 3 months before start of study;
- life-time psychosis;
- acute suicide risk;
- current state of asthma or COPD, which necessitates medication use;
- cardiovascular diseases or irregular heartbeat;
- hypotension or hypertension;
- pregnancy or breastfeeding;
- epilepsy;
- any medication contra-indicative of the use of propranolol.

Study & Design

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