Overview
Sponsor-declared trial summary
psychological disorders: PTSD; Anxiety disorders
to examine the effects of a 2-week administration of Cannabidiol (CBD) in alleviating anxiety symptoms before anxiety or PTSD treatments in Dutch uniformed personnel
Key facts
- Sponsor
- Universitair Medisch Centrum Utrecht
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 29 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Brain Research and Innovation Center, Ministry of Defense
External identifiers
- EU CT number
- 2024-514783-78-00
- EudraCT number
- 2020-003739-62
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
to examine the effects of a 2-week administration of Cannabidiol (CBD) in alleviating anxiety symptoms before anxiety or PTSD treatments in Dutch uniformed personnel
Secondary objectives 1
- 1. Examine the effects of fear extinction and consolidation of a fear conditioning paradigm 2. study the effect of CBD on stress regulation 3. Examine the effects of CBD on sleep quality
Conditions and MedDRA coding
psychological disorders: PTSD; Anxiety disorders
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Dutch uniformed personnel, which are (former) police-officers, firefighters, ambulance paramedics, military personnel or veterans.
- Age between 18-65
- Waiting for therapy for the treatment of a trauma and stressor-related and/or an anxiety disorder (as determined by the MINI PLUS psychiatric interview)
Exclusion criteria 9
- Severe co-morbidity (severe major depressive or bipolar disorder and/or psychosis)
- Alcohol and/or drug dependence
- Inability to adequately read or speak Dutch
- (a history of) epilepsy or brain damage, cardiac, renal or liver abnormalities
- (a history of) allergies to medication (adverse reactions or rash)
- Individuals taking certain medications known to have potential interactions with CBD (i.e., steroids, HMG-CoA reductase inhibitors, calcium channel blockers, antihistamines, antivirals, immune modulators, benzodiazepines, anti-arrhythmic, antibiotics, anesthetics, antipsychotics, antidepressants, anti-epileptics, beta blockers, proton pump inhibitors, NSAIDs, angiotensin II blockers, oral hypoglycemic agents, and sulfonylureas)
- Used cannabis, synthetic cannabinoid, cannabinoid analogue, or any CBD or THC-containing product within 30 days of eligibility screening.
- Individuals that had been diagnosed with intestinal, liver, or renal diseases that would affect absorption or clearance of CBD
- For women: pregnant, a wish to become pregnant, or nursing
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Beck’s anxiety index between the first and second week.
Secondary endpoints 3
- Effect of CBD on Fear extinction (i.e. physiological responses and subjective fear)
- Effect of CBD on stress regulation with the Maastricht Acute Stress Test (MAST; i.e. Subjective stress, physiological responses, alpha-amylase and cortisol)
- Effect of CBD on Sleep quality (i.e. questionnaires and a sleep watch)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11647816 · Product
- Active substance
- Cannabidiol
- Substance synonyms
- CBD
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITAIR MEDISCH CENTRUM UTRECHT
- Paediatric formulation
- No
- Orphan designation
- No
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
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
- Remco van Zijderveld
Public contact point
- Organisation
- Universitair Medisch Centrum Utrecht
- Contact name
- Remco van Zijderveld
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 82 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-10-29 | 2024-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-514783-78-00_For_Publication | 11 |
| Recruitment arrangements (for publication) | K1_blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_2024514783-78 | 10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Netherlands | Acceptable 2024-10-29
|
2024-10-29 |