BridgeMD
EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL
EU CTIS ID: 2025-520778-20-00
What this study is testing
Evaluation of the effect of cholecalciferol treatment in subjects with depressive disorder or bipolar disorder after 12 weeks.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Osteoporosis or previous fragility fractures
- 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
See the full eligibility criteria
- 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.
- Osteoporosis or previous fragility fractures
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.