Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
196
Countries
1
Sites
4
Posttraumatic Stress Disorder (PTSD)
The main objective is to investigate whether hydrocortisone, compared to placebo, leads to lower clinician-assessed PTSD symptomology 3 months after trauma.
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2026-03-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Dutch Brain Foundation (Hersenstichting Nederland)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Efficacy
The main objective is to investigate whether hydrocortisone, compared to placebo, leads to lower clinician-assessed PTSD symptomology 3 months after trauma.
Secondary objectives 5
- To investigate whether hydrocortisone, compared to placebo, leads to a lower risk of a clinician-assessed PTSD diagnosis 3 months after trauma.
- To investigate whether hydrocortisone, compared to placebo, leads to lower long-term self-reported PTSD symptomology after trauma.
- To investigate whether hydrocortisone, compared to placebo, leads to better other long-term outcomes after trauma: mood, quality of life and cost-effectiveness, alcohol use, sleep quality, SAEs, patient-reported outcomes.
- To investigate descriptive potential moderators/mediators of the effect of hydrocortisone treatment on the abovementioned outcomes.
- To evaluate the intervention and explore scalability and implementation of our approach through qualitative analysis.
Conditions and MedDRA coding
Posttraumatic Stress Disorder (PTSD)
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-523350-13-00 | SHIELD – Swift Hydrocortisone Intervention after trauma exposure | Amsterdam UMC Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age: 18 to 65
- Sex/gender: any
- Proficiency in Dutch
- 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 4
- Not able to give informed consent
- Not allowed to take hydrocortisone
- Psychiatric counterindications assessed through anamnesis
- Practical exclusion criteria (e.g., no reliable access to telephone or internet)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PTSD symptom severity at 3 months (T4) after the intervention, measured with the CAPS-5 score.
Secondary endpoints 5
- Status of PTSD diagnosis at 3 months (T4) after the intervention, measured with the CAPS-5.
- 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.
- Scores on the questionnaires assessing other outcomes (IDS-SR, EQ-5D-5L, AUDIT, ISI) and SAEs at T1 to T6.
- 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.
- Results of qualitative interviews with 20 participants of the trial
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hydrocortison Hualan 10 mg, tabletten
PRD11103023 · Product
- Active substance
- Hydrocortisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- RVG 129641
- MA holder
- HUALAN
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulation (for blinding)
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Christiaan Vinkers
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Christiaan Vinkers
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 196 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC Stichting
Psychiatry, De Boelelaan 1117, 1081 HV, Amsterdam
Diakonessenhuis Stichting
Emergency Department, Bosboomstraat 1, 3582 KE, Utrecht
Stichting Viecuri Medisch Centrum voor Noord-Limburg
Emergency Department, Tegelseweg 210, 5912 BL, Venlo
Radboud universitair medisch centrum Stichting
Psychiatry, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523350-13-02 redacted | 3 |
| Protocol (for publication) | D4_Patient facing documents Alcohol Use Disorders Identification Test AUDIT | 1 |
| Protocol (for publication) | D4_Patient facing documents Body Mass Index BMI | 1 |
| Protocol (for publication) | D4_Patient facing documents Childhood Trauma Questionnaire CTQ | 1 |
| Protocol (for publication) | D4_Patient facing documents Clinician-Administered PTSD Scale for DSM-5 CAPS-5 | 2 |
| Protocol (for publication) | D4_Patient facing documents Daily PTSD-Checklist for DSM-5 PCL-5 | 2 |
| Protocol (for publication) | D4_Patient facing documents Demographics | 1 |
| Protocol (for publication) | D4_Patient facing documents Drug Use | 1 |
| Protocol (for publication) | D4_Patient facing documents Eindscherm online vragenlijsten | 1 |
| Protocol (for publication) | D4_Patient facing documents EuroQol-5 Dimension-5 Level EQ-5D-5L | 1 |
| Protocol (for publication) | D4_Patient facing documents Insomnia Severity Index ISI | 1 |
| Protocol (for publication) | D4_Patient facing documents Inventory of Depressive Symptomatology-Self Report IDS-SR | 1 |
| Protocol (for publication) | D4_Patient facing documents Life Events Checklist for DSM-5 LEC-5 | 2 |
| Protocol (for publication) | D4_Patient facing documents Medication Screening | 2 |
| Protocol (for publication) | D4_Patient facing documents Menstruation Hormonal Phase and Anticonception | 2 |
| Protocol (for publication) | D4_Patient facing documents Patient Experience | 1 |
| Protocol (for publication) | D4_Patient facing documents PTSD Check-in | 2 |
| Protocol (for publication) | D4_Patient facing documents Side Effects Study Medication | 1 |
| Protocol (for publication) | D4_Patient facing documents Sleep Diary | 1 |
| Protocol (for publication) | D4_Patient facing documents Study Medication Adherence | 1 |
| Protocol (for publication) | D4_Patient facing documents Suicidality Screening | 1 |
| Protocol (for publication) | D4_Patient facing documents Tobacco Use | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material flyer | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults redacted | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Hualan | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2025-523350-13-02 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-02 | Netherlands | Acceptable 2026-03-16
|
2026-03-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-26 | Netherlands | Acceptable | 2026-04-17 |