AuthorisedPhase III and phase IV (Integrated)Interventional

EFFECTIVENESS OF SUPPLEMENTATION WITH VITAMIN D IN PATIENTS WITH DEPRESSIVE DISORDER OR BIPOLAR DISORDER: A RANDOMIZED CONTROLLED CLINICAL TRIAL

This study is trying to find out if vitamin D supplements can help people who have depression or bipolar disorder. Researchers will give some people vitamin D and others a 'dummy' treatment (like olive oil) to see if there's a difference. They will carefully measure changes in how people feel using a special rating scale for depression over 12 and 24 weeks. The main goal is to see if vitamin D helps reduce depression symptoms and helps people feel better. They will also check if vitamin D levels in the blood change. This study is for adults and includes both men and women.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Azienda Ospedaliera Universitaria Senese

Enrolment target

150

Start

10 Feb 2025

Depressive disorder Bipolar disorder

What is this study about?

This study is investigating whether taking vitamin D supplements can improve the symptoms of depression in people who have either depression or bipolar disorder. Many people in the UK don't get enough vitamin D, especially during winter. There's some early evidence that vitamin D might play a role in how our brains work and how we feel, but more research is needed to be sure if it can really help with mental health conditions like depression.

To find this out, participants will be randomly assigned to one of two groups. One group will receive vitamin D supplements, and the other group will receive a 'dummy' treatment, which is essentially olive oil. Neither the participants nor the doctors will know who is getting which treatment. This is to make sure the study results are fair and not influenced by what people expect.

The main thing researchers want to know is if people's depression symptoms get better after 12 weeks of treatment, as measured by a specific depression rating scale. They also want to see how long it takes for depression symptoms to significantly improve or go away. They'll continue to track changes in symptoms at 24 weeks and also check if vitamin D levels in people's blood change over time. This will help them understand if vitamin D could be a useful extra treatment for these conditions.

Key takeaways

This study is testing if vitamin D helps depression in people with depressive or bipolar disorder.
Participants will get either vitamin D or harmless olive oil.
Results will be measured using depression scales and blood tests.
The study lasts for 24 weeks.
It's for adults (18+) with a diagnosis of depressive or bipolar disorder.

Who may be eligible?

This study is looking for adults aged 18 or older to take part. Both men and women are welcome to join. You would need to have been diagnosed with either depressive disorder or bipolar disorder by a doctor.

There might be other reasons why someone can't join the study, even if they fit the age and diagnosis criteria. For example, people with certain other health conditions or those taking specific medications might not be able to participate. This is to ensure the study is safe for everyone involved and that the results are clear.

If you are interested, the study team will go through a full checklist with you to make sure you are a good fit for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with depressive disorder or bipolar disorder?
Are you able to attend regular study appointments for 24 weeks?
Are you comfortable with taking either a vitamin D supplement or an olive oil supplement?
Are you comfortable with having blood tests at various times during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to either receive a vitamin D supplement or a dummy treatment (olive oil) in a single-dose liquid form. You would take this treatment as instructed by the study team. You would attend regular appointments with the study team over 24 weeks. At these appointments, you would have your depression symptoms assessed using a short questionnaire known as the Montgomery-Asberg Depression Rating Scale (MADRS). You'd also have blood tests to check your vitamin D levels at the start and at different points throughout the study. The total duration of your active involvement in the study would be about 24 weeks.

Potential risks and benefits

Taking part in this study could potentially help us learn more about how to treat depression and bipolar disorder, which could benefit many patients in the future. You might find that your depressive symptoms improve if you receive the active vitamin D supplement. However, there's also a chance you might receive the dummy treatment, which would not have a direct effect on your symptoms. While vitamin D is generally safe, there can be very rare side effects with any medication or supplement. The study team will explain any potential risks in detail, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is a 'dummy treatment'?

A 'dummy treatment' (also called a placebo) is a treatment that looks exactly like the real medicine but contains no active ingredients, like olive oil in this study. It helps researchers fairly compare the active treatment.

Will I know if I'm getting vitamin D or the dummy treatment?

No, neither you nor your doctor will know which treatment you are receiving until after the study is finished. This helps to keep the study fair and unbiased.

How often will I need to visit the clinic?

You will need to attend regular appointments over 24 weeks. The study team will give you a detailed schedule of visits.

What is the Montgomery-Asberg Depression Rating Scale (MADRS)?

The MADRS is a common and trusted questionnaire that doctors use to measure how severe someone's depression symptoms are. It helps track changes over time.

Can I stop taking part in the study if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your regular medical care.