Overview
Sponsor-declared trial summary
Depressive disorder
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.
Key facts
- Sponsor
- Azienda Ospedaliera Universitaria Senese
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Decision date (initial)
- 2025-02-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520778-20-00
- EudraCT number
- 2018-003313-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.
Conditions and MedDRA coding
Depressive disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age 18-75 years
- Subjects referred to the Psychiatry Unit of the Entity at the Azienda Ospedaliera Universitario Senese with a diagnosis of major depressive disorder or disorder bipolar
- MADRS score >15
- Serum level of 25(OH) Vitamin D< 20 ng/ml
- Stable antipsycothic therapy (at least two weeks)
- Patients able to take Vitamin D supplementation (oral formulation)
- Willingness to provide free and informed consent.
Exclusion criteria 16
- Osteoporosis or previous fragility fractures
- Osteomalacia or Paget's disease
- Diseases known to have interference with vitamin D metabolism (sarcoidosis, hypercalcemia, renal failure)
- Pregnancy or lactation
- Secondary osteoporosis (primary or secondary hyperparathyroidism, hyperprolactinemia, etc.)
- Therapy with estrogens, drugs for osteoporosis, or drugs known to have interference with bone metabolism (antiepileptics, cortisone, antiretrovirals, heparin etc.)
- Diabetes mellitus types 1 and 2
- Lipid metabolism disorders
- Body Mass Index of less than 18 or more than 34.9 kg/sqm
- Drug abuse
- Therapy with calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months
- Neoplastic disease or severe liver, kidney or gastrointestinal disease
- Severe cognitive impairment
- Acute psychosis
- Inability to answer questions
- Refusal to sign informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment
- Time to remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS≤ 10)
Secondary endpoints 2
- Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks
- Changes in 25OH vitamin D levels at 12 and 24 weeks
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
DIBASE 50.000 U.I./2,5 ml soluzione orale in contenitore monodose
PRD1575455 · Product
- Active substance
- Colecalciferol
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 7143 U unit(s)
- Max total dose
- 1200000 U unit(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- 036635062
- MA holder
- ABIOGEN PHARMA S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Olive oil, refined vehicle 2,5 ml (quality standard Ph. Eur. current edition monograph 1456)
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
Azienda Ospedaliera Universitaria Senese
- Sponsor organisation
- Azienda Ospedaliera Universitaria Senese
- Address
- Strada Delle Scotte 14
- City
- Siena
- Postcode
- 53100
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliera Universitaria Senese
- Contact name
- Clinical Trial Office
Public contact point
- Organisation
- Azienda Ospedaliera Universitaria Senese
- Contact name
- Clinical Trial Office
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 5.0 |
| Recruitment arrangements (for publication) | Not applicable | 1 |
| Subject information and informed consent form (for publication) | ICF Vit D v 1 2 14 02 2024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | RCP Colecalciferolo | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-28 | Italy | Acceptable 2025-01-30
|
2025-02-10 |