Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
100
Countries
1
Sites
1
Mimic an acute stress response in humans.
The main objective of the trial is to observe the effects of yohimbine and/or hydrocortisone on moral judgement in military personnel.
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01]
- Trial duration
- 18 Jul 2024 → 30 Jun 2025
- Decision date (initial)
- 2024-04-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ministry of Defence
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The main objective of the trial is to observe the effects of yohimbine and/or hydrocortisone on moral judgement in military personnel.
Secondary objectives 1
- The secondary objectives of the trial are the effects of yohimbine and/or hydrocortisone on working memory, impulse control, and risk taking in military personnel.
Conditions and MedDRA coding
Mimic an acute stress response in humans.
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Testing day - English Participants will take part in one day of experimental testing, with the duration expected to be around 150 min.
|
Randomised Controlled | Double | [{"id":109781,"code":4,"name":"Analyst"},{"id":109783,"code":2,"name":"Investigator"},{"id":109782,"code":1,"name":"Subject"}] | Yohimbine and placebo: 30 mg yohimbine and placebo. Hydrocortisone and placebo: 30 mg hydrocortisone and placebo. Yohimbine and hydrocortisone: Both 30 mg yohimbine and 30 mg hydrocortisone. Double placebo: Double placebo group. |
| 2 | Test dag - Nederlands Deelnemers zullen een dag deelnemen in het experiment, waarbij de enkele experimentele sessie verwacht wordt ongeveer 150 min te duren.
|
Randomised Controlled | Double | [{"id":109785,"code":1,"name":"Subject"},{"id":109786,"code":2,"name":"Investigator"},{"id":109787,"code":4,"name":"Analyst"}] | Yohimbine en placebo: 30 mg yohimbine en placebo. Hydrocortison and placebo: 30 mg hydrocortison en placebo. Yohimbine en hydrocortison: Zowel 30 mg yohimbine als 30 mg hydrocortison. Dubbele placebo: Dubbele placebo groep. |
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Coded data will be made available upon request. This data can then be used for instance to replicate the results. Data will be coded in such a way that it is not traceable to the subject.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-508731-31-00 | Understanding the Neurobiology of Pharmacologically-induced Acute Stress on Ethical Decisions | Universitair Medisch Centrum Utrecht |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age ≥ 18 years and < 60 years old.
- Active duty military member.
Exclusion criteria 6
- Receiving current psychological treatment.
- Current or previous heart and/or vascular disease.
- Current or previous endocrine disease/endocrinal deficits.
- Use of recreational substances in the last four weeks.
- Medication use that interact with either yohimbine or hydrocortisone in the last week.
- Pregnancy, menstruation or contraceptives.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The number of utilitarian, deontological, and compromise choices made in a behavioural task measuring moral judgement.
- The number of violations in rationality when making moral decisions.
Secondary endpoints 3
- The total score of the forward, backward, and sequencing digit span of the Digit Span Task, an assessment of working memory.
- The stop signal reaction time of the Stop Signal Task, assessment of impulse control.
- The mean adjusted amount of button clicks and total number of exploded balloons for each risk condition in the Balloon Analogue Risk Taking task, assessment for risk-taking.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD2704547 · Product
- Active substance
- Yohimbine Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- G04BE04 — YOHIMBIN
- Marketing authorisation
- BE250302
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- English: encapsulated in dosages of 10 mg and additionally filled with cellulose microcrystalline. Nederlands: geëncapsuleerd in een dosering van 10 mg en daarnaast aangevuld met cellulose microkristallijn.
Hydrocortison Teva 10 mg, filmomhulde tabletten
PRD10133220 · Product
- Active substance
- Hydrocortisone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- RVG 130124
- MA holder
- TEVA B.V
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- English: encapsulated in dosages of 10 mg and additionally filled with cellulose microcrystalline. Nederlands: geëncapsuleerd in een dosering van 10 mg en daarnaast aangevuld met cellulose microkristallijn.
Placebo 1
SUB12626MIG · Substance
- Active substance
- Cellulose, Microcrystalline
- Pharmaceutical form
- ORAL POWDER
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 30 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Utrecht
- Sponsor organisation
- Universitair Medisch Centrum Utrecht
- Address
- Heidelberglaan 100
- City
- Utrecht
- Postcode
- 3584 CX
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Coordinating researcher trial
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Coordinating researcher trial
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
Psychiatry, Heidelberglaan 100, 3584 CX, Utrecht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-07-18 | 2025-06-30 | 2024-10-03 | 2025-06-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508731-31-01 | 4 |
| Protocol (for publication) | D1_Protocol 2023-508731-31-01_TC | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material flyer - poster | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material website text | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_TC | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Hydrocortison Teva 10 mg tablet | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Yocoral 5 mg tablet | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2023-508731-31-01 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2023-508731-31-01 | 2 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-18 | Netherlands | Acceptable 2024-04-25
|
2024-04-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-13 | Netherlands | Acceptable 2024-07-02
|
2024-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-27 | Netherlands | Acceptable 2025-03-17
|
2025-03-24 |