Clinical trial • Phase II • Psychiatry
HYDROCORTISONE for Post-traumatic stress disorder (PTSD)
Phase II trial of HYDROCORTISONE for Post-traumatic stress disorder (PTSD).
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Post-traumatic stress disorder (PTSD)
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 02-12-2025
- First CTIS Authorization Date
- 17-03-2026
Trial design
Hydrocortison Hualan 10 mg tablets (oral) as test medication; placebo pills matched in appearance and over-encapsulated with the same capsule as the test medication. Hydrocortison product details: 10 mg tablets; dose unit mg; max daily dose amount 30 mg; max total dose amount 120 mg; max treatment period 4 (time unit code 1). Exact dosing schedule and randomisation details not specified in the provided record.-controlled Phase II trial across 4 sites in Netherlands.
- Comparator
- Hydrocortison Hualan 10 mg tablets (oral) as test medication; placebo pills matched in appearance and over-encapsulated with the same capsule as the test medication. Hydrocortison product details: 10 mg tablets; dose unit mg; max daily dose amount 30 mg; max total dose amount 120 mg; max treatment period 4 (time unit code 1). Exact dosing schedule and randomisation details not specified in the provided record.
- Target Sample Size
- 196
- Trial Duration For Participant
- 365
Eligibility
Recruits 196 Vulnerable population selected. Participants must be able to give informed consent; "Not able to give informed consent" is an exclusion criterion. Subject information and informed consent form for adults (L1_SIS and ICF adults redacted) available. No assent provisions for minors (study includes adults 18-65 only)..
- Vulnerable Population
- Vulnerable population selected. Participants must be able to give informed consent; "Not able to give informed consent" is an exclusion criterion. Subject information and informed consent form for adults (L1_SIS and ICF adults redacted) available. No assent provisions for minors (study includes adults 18-65 only).
Inclusion criteria
- {"criterion_text":"- Age: 18 to 65"}
- {"criterion_text":"- Sex/gender: any"}
- {"criterion_text":"- Proficiency in Dutch"}
- {"criterion_text":"- Presented at ED as a result of a one-time incident involving injury as a result of an accident, physical or sexual violence or another kind of exceptional situation"}
Exclusion criteria
- {"criterion_text":"- Not able to give informed consent"}
- {"criterion_text":"- Not allowed to take hydrocortisone"}
- {"criterion_text":"- Psychiatric counterindications assessed through anamnesis"}
- {"criterion_text":"- Practical exclusion criteria (e.g., no reliable access to telephone or internet)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PTSD symptom severity at 3 months (T4) after the intervention, measured with the CAPS-5 score.","definition_or_measurement_approach":"Measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at 3 months (T4) after intervention."}
Secondary endpoints
- {"endpoint_text":"- Status of PTSD diagnosis at 3 months (T4) after the intervention, measured with the CAPS-5.","definition_or_measurement_approach":"Clinician-assessed PTSD diagnosis using the CAPS-5 at 3 months (T4)."}
- {"endpoint_text":"- Self-reported PTSD symptom severity at 2 weeks (T1), 1 month (T2), 6 weeks (T3), 3 months (T4), 6 months (T5) and 12 months (T6) after the intervention, measured with the PCL-5.","definition_or_measurement_approach":"Participant self-report using the PCL-5 at specified timepoints T1–T6."}
- {"endpoint_text":"- Scores on the questionnaires assessing other outcomes (IDS-SR, EQ-5D-5L, AUDIT, ISI) and SAEs at T1 to T6.","definition_or_measurement_approach":"Questionnaire scores (IDS-SR, EQ-5D-5L, AUDIT, ISI) and recording of (serious) adverse events across T1–T6."}
- {"endpoint_text":"- Demographic data, scores on questionnaires (CTQ, LEC-5), wearable measuring heart rate (HR) and heart rate variability (HRV), intrusion and sleep diary, saliva sample collected at intake, self-composed questionnaires.","definition_or_measurement_approach":"Collection of baseline demographics, questionnaire scores (CTQ, LEC-5), physiological data from wearable (HR, HRV), diaries (intrusion, sleep), saliva sample at intake, and bespoke questionnaires."}
- {"endpoint_text":"- Results of qualitative interviews with 20 participants of the trial","definition_or_measurement_approach":"Qualitative interviews conducted with 20 participants; results analysed qualitatively."}
Recruitment
- Planned Sample Size
- 196
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent is required from participants (adult ICF available: 'L1_SIS and ICF adults redacted'). Participants must be able to give informed consent (those not able to give informed consent are excluded). Inclusion requires proficiency in Dutch; study documentation and public translations include Dutch. No minor assent procedures (min age 18).
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 196
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-03-2026
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 37
- Number Of Sites
- 4
- Number Of Participants
- 196
Sites
- Site Name
- Diakonessenhuis Stichting
- Department Name
- Emergency Department
- Contact Person Name
- David Baden
- Contact Person Email
- dbaden@diakhuis.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Psychiatry
- Contact Person Name
- Christiaan Vinkers
- Contact Person Email
- ctis@amsterdamumc.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Psychiatry
- Contact Person Name
- Erno Hermans
- Contact Person Email
- erno.hermans@radboudumc.nl
- Site Name
- Stichting Viecuri Medisch Centrum voor Noord-Limburg
- Department Name
- Emergency Department
- Contact Person Name
- Dennis Barten
- Contact Person Email
- dbarten@viecuri.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Netherlands
Third parties
- {"country":"","full_name":"Dutch Brain Foundation (Hersenstichting Nederland)","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Hydrocortison Hualan 10 mg, tabletten
- Active Substance
- HYDROCORTISONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: RVG 129641; prodAuthStatus: 2)
- Starting Dose
- 10 mg (product: 10 mg tablet)
- Maximum Dose
- Max daily dose 30 mg; max total dose 120 mg
- Investigational Product Name
- Placebo pills will be matched in appearance and over-encapsulated with the same capsule as the test medication.
- Modality
- Other
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