Clinical trial • Psychiatry
Colecalciferol (cholecalciferol) for Depressive disorder | Bipolar disorder
Clinical trial of Colecalciferol (cholecalciferol) for Depressive disorder | Bipolar disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Depressive disorder | Bipolar disorder
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 27-01-2025
- First CTIS Authorization Date
- 10-02-2025
Trial design
Randomised, dibase 50.000 u.i./2,5 ml oral solution (cholecalciferol) versus placebo (olive oil, refined vehicle 2,5 ml).-controlled trial across 1 site in Italy.
- Randomised
- Yes
- Comparator
- DIBASE 50.000 U.I./2,5 ml oral solution (cholecalciferol) versus placebo (Olive oil, refined vehicle 2,5 ml).
- Target Sample Size
- 150
- Trial Duration For Participant
- 168
Eligibility
Recruits 150 No vulnerable populations selected; participants must provide free and informed consent (criterion: 'Willingness to provide free and informed consent.'). Refusal to sign informed consent is an exclusion ('Refusal to sign informed consent'). No assent procedure mentioned; only adults (Age 18-75 years) are eligible..
- Pregnancy Exclusion
- Pregnancy or lactation
- Vulnerable Population
- No vulnerable populations selected; participants must provide free and informed consent (criterion: 'Willingness to provide free and informed consent.'). Refusal to sign informed consent is an exclusion ('Refusal to sign informed consent'). No assent procedure mentioned; only adults (Age 18-75 years) are eligible.
Inclusion criteria
- {"criterion_text":"- Age 18-75 years\n- 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\n- MADRS score >15\n- Serum level of 25(OH) Vitamin D< 20 ng/ml\n- Stable antipsycothic therapy (at least two weeks)\n- Patients able to take Vitamin D supplementation (oral formulation)\n- Willingness to provide free and informed consent."}
Exclusion criteria
- {"criterion_text":"- Osteoporosis or previous fragility fractures\n- Osteomalacia or Paget's disease\n- Diseases known to have interference with vitamin D metabolism (sarcoidosis, hypercalcemia, renal failure)\n- Pregnancy or lactation\n- Secondary osteoporosis (primary or secondary hyperparathyroidism, hyperprolactinemia, etc.)\n- Therapy with estrogens, drugs for osteoporosis, or drugs known to have interference with bone metabolism (antiepileptics, cortisone, antiretrovirals, heparin etc.)\n- Diabetes mellitus types 1 and 2\n- Lipid metabolism disorders\n- Body Mass Index of less than 18 or more than 34.9 kg/sqm\n- Drug abuse\n- Therapy with calcifediol, calcitriol, cholecalciferol or calcium supplementation in progress or in the previous two months\n- Neoplastic disease or severe liver, kidney or gastrointestinal disease\n- Severe cognitive impairment\n- Acute psychosis\n- Inability to answer questions\n- Refusal to sign informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in Montgomery-Asberg Depression Rating Scale - MADRS at 12 weeks of treatment","definition_or_measurement_approach":"Change in MADRS score measured at 12 weeks of treatment (Montgomery-Asberg Depression Rating Scale)."}
- {"endpoint_text":"- Time to remission of depressive disorder (Montgomery-Asberg Depression Rating Scale -MADRS≤ 10)","definition_or_measurement_approach":"Time to remission defined as time until MADRS ≤ 10."}
Secondary endpoints
- {"endpoint_text":"- Changes in Montgomery-Asberg Depression Rating Scale (MADRS) score at 24 weeks","definition_or_measurement_approach":"Change in MADRS score measured at 24 weeks."}
- {"endpoint_text":"- Changes in 25OH vitamin D levels at 12 and 24 weeks","definition_or_measurement_approach":"Measurement of serum 25-hydroxyvitamin D levels at 12 and 24 weeks."}
Recruitment
- Planned Sample Size
- 150
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent is required from each participant (ICF document available: 'ICF Vit D v 1 2 14 02 2024'). Inclusion requires 'Willingness to provide free and informed consent.' Refusal to sign informed consent is an exclusion. Only adults (18-75 years) eligible. No information on assent or languages provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 150
Italy
- Earliest CTIS Part Ii Submission Date
- 27-01-2025
- Latest Decision Or Authorization Date
- 10-02-2025
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 150
Sites
- Site Name
- Azienda Ospedaliera Universitaria Senese
- Department Name
- U.O.C. Psichiatria
- Principal Investigator Name
- Andrea Fagiolini
- Principal Investigator Email
- a.fagiolini@ao-siena.toscana.it
- Contact Person Name
- Andrea Fagiolini
- Contact Person Email
- a.fagiolini@ao-siena.toscana.it
- Number Of Participants
- 150
Sponsor
Primary sponsor
- Full Name
- Azienda Ospedaliera Universitaria Senese
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- DIBASE 50.000 U.I./2,5 ml soluzione orale in contenitore monodose
- Active Substance
- Colecalciferol (cholecalciferol)
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 036635062; authorisationCountryCode: IT; euMpNumber: PRD1575455)
- Starting Dose
- 50,000 U.I. in 2.5 ml (product formulation)
- Maximum Dose
- 7143 U unit(s) per day (maxDailyDoseAmount); max total 1200000 U unit(s)
- Investigational Product Name
- Olive oil, refined vehicle 2,5 ml (quality standard Ph. Eur. current edition monograph 1456)
- Modality
- Other
- Starting Dose
- 2.5 ml vehicle
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