Cortisol in personalized treatment for posttraumatic stress disorder (PTSD)

Phase 1

• Conditions: Posttraumatic Stress Disorder (PTSD); MedDRA version: 20.0Level: LLTClassification code 10036876Term: Prolonged posttraumatic stress disorderSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-000712-30-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-08
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Patient group:
Participants with PTSD (n = 160), or suspected diagnosis, who will start trauma-focused therapy, will be recruitedbefore the start of their treatment at collaborating treatment centres. Patients must be aged 18-64. The expectedwaiting time until treatment is sufficient for participation, at least for part A of the study. Inclusion of patients intosubstudy B follows a selection procedure based on HPA axis dysregulation and feasibility.

Control group:
Healthy, non-trauma exposed control participants (n = 30) will be recruited from the general population in and around Nijmegen. Control participants only complete assessments from substudy A. Control participants must be aged 18-64 years. Inclusion criteria are no history of psychiatric disorders, and no history of childhood maltreatment. Hence, this group will reflect a healthy, non-trauma exposed control group, Control participants will be selected based on age, gender and education, with the aim to match the distributions of these relevant basic demographic variables to the (expected) distributions of the included patient group.

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 190
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient group:
•Current episode of psychotic or manic symptoms.
•Daily intake of benzodiazepines, or otherwise irregular intake of benzodiazepines (when needed”) but unable to withhold intake from the day prior to each test session until the end of the each test session. An exception is made for low doses of short-acting benzodiazepines that are prescribed for insomnia (i.e. as sleep medication).
•A relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis) or severe physical disorder which is likely to impact assessment procedures or results.
•Reports to be unable or unwilling to withhold recreational drug use and limit alcohol use from the day prior to each test session until the end of the each test session.
•General learning disability, or known to have intelligence Quotient (IQ) < 80
•Body Mass Index (BMI) of >30.
•Current or recent endocrine treatment (<1 month ago; for e.g., phechromocytoma, hyperthyroidism, Cushing’s syndrome).
•Current or recent regular use of corticosteroids (<1 month ago).
•For women: Pregnancy.
•Reports hypersensitivity to hydrocortisone or any of the tablet’s auxiliary agents.
•(Only for part B) Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, metal in or around the body, deep brain stimulation, severe claustrophobia).

Note: based on the exclusion criteria above, it may be decided by the research team that a participant should onlyparticipate in part A of the study, but will be excluded from part B of the study

Control group:
•History of childhood maltreatment
•Current or past psychiatric disorder
•Use of psychotropic medication
•Relevant neurological disorder (e.g., stroke, epilepsy, Multiple Sclerosis) or severe physical disorder which is likely to impact assessment procedures or results.
•Reports to be unable or unwilling to withhold recreational drug use and limit alcohol use from the day prior to each test session until the end of the each test session.
•General learning disability, or known to have intelligence Quotient (IQ) < 80
•Body Mass Index (BMI) of >30.
•Current or recent endocrine treatment (<1 month ago; for e.g., phechromocytoma, hyperthyroidism, Cushing’s syndrome).
•Current or recent regular use of corticosteroids (<1 month ago).
•For women: Pregnancy.

Study & Design

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