Not yet recruitingPHASE3INTERVENTIONAL

Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia

This study is for adults aged 18-65 who have both major depression and trouble sleeping (insomnia). Many people with depression don't get much better with just antidepressants, especially when they also have insomnia. This trial is trying to find out if adding two special types of treatment, called chronotherapies, can help more. These are light therapy, which helps regulate sleep, and prolonged-release melatonin, a hormone that also helps with sleep. All participants will receive an antidepressant and advice on good sleep habits. The study will test these treatments alone or in combination, compared to placebos (dummy treatments), to see if they can reduce depression symptoms more effectively over 8 weeks, improving outcomes for those who struggle with current treatments.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

184

Start

01 Sep 2025

Estimated completion

01 May 2029

Major Depressive Disorder (MDD) With Insomnia

What is this study about?

This study is looking into better ways to help adults who are dealing with both major depression and insomnia (trouble sleeping). A lot of people find that even with common antidepressant medicines, their depression doesn't fully go away, especially when they also have a hard time sleeping. In fact, more than half of people don't get enough relief from just antidepressants, and insomnia often makes things worse and is a sign that treatment might be harder.

Researchers want to see if adding two specific treatments, called "chronotherapies," can make a difference. These are light therapy, which involves using a special lamp, and a slow-release form of melatonin, a natural substance that helps control sleep. Both of these treatments have shown promise in helping with depression and improving sleep patterns. Light therapy has been found to work well, sometimes as effectively as antidepressants, and can double their effectiveness when used together. Melatonin is also known for helping with sleep problems related to depression.

In this study, everyone will receive an antidepressant medicine and advice on how to improve their sleep habits. Then, they will be given either the real light therapy, real melatonin, both real treatments, or placebo (dummy) versions of these over 8 weeks. The main goal is to see if these combinations can significantly reduce depression symptoms more than current treatments alone, offering hope for the many people who haven't fully recovered.

Key takeaways

Targets adults with both major depression and insomnia.
Investigates antidepressant alongside light therapy and melatonin.
Aims to improve outcomes for those not fully responding to current treatments.
Compares real treatments to placebo (dummy) versions.
Participation involves 8 weeks of treatment and regular check-ups.

Who may be eligible?

This study is looking for adults between 18 and 65 years old who have been diagnosed with a major depressive episode and also experience insomnia. You must be receiving care for your depression at a psychiatric or sleep medicine department, and not have started a new antidepressant for your current episode within the last month. Your depression and insomnia symptoms need to be at least moderate.

There are some reasons you wouldn't be able to join. For instance, if you have certain eye conditions like cataracts or glaucoma, or problems with your retina. You also can't take part if you have other severe mental health conditions like bipolar disorder or schizophrenia, or if you are pregnant or breastfeeding. If you've recently had light therapy within the last month, you won't be eligible. Also, if you have very long sleep times due to your depression, this study won't be suitable for you.

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 between 18 and 65 years old?
Have you been diagnosed with major depression and also have trouble sleeping?
Do you *not* have certain eye conditions like cataracts or glaucoma?
Are you *not* pregnant or breastfeeding?
Have you *not* had light therapy in the last month?

Answer every question to see your result.

What does participation involve?

If you join this study, everyone will receive an antidepressant and advice on improving their sleep. You'll then be randomly assigned to one of four groups. Some groups will use a special light therapy lamp, and others will use a dummy (placebo) lamp. Similarly, some groups will take a 2mg slow-release melatonin tablet, and others will take a dummy tablet. You won't know which treatment you're receiving. The active treatments or placebos will be used for 8 weeks.

Throughout the 8 weeks, you'll have regular visits where researchers will check your overall health, how you're feeling, and your depression and sleep symptoms using questionnaires and discussions. The main way they'll measure progress is by tracking changes in your depression score. After the 8-week treatment period, there will likely be follow-up observations to see how you're doing. The total duration of active participation is 8 weeks.

Potential risks and benefits

Potential benefits of taking part could include an improvement in your depression symptoms and sleep, especially if the combination of treatments works better than standard care. You would also be contributing to important research that could help others with depression and insomnia in the future. Potential risks might include side effects from the antidepressant, light therapy, or melatonin, though these are generally considered safe. There's also a chance you might not receive the active treatments if you're in a placebo group. Be aware that light therapy can cause temporary eye strain or headaches for some. You are free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Hôpital Bichat-Claude Bernard
Verified postcode
Paris, France

Common questions

What is 'chronotherapy'?

Chronotherapy means treatments that help reset your body's natural clock, like sleep-wake cycles, often using light or hormones like melatonin.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real thing but contains no active medicine or ingredient. It helps researchers see if a treatment truly works.

Will I know if I'm getting the real treatment or a placebo?

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know whether you are getting the real treatments or the placebos.

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

It's a common questionnaire used by doctors to measure the severity of depression symptoms to see if they improve over time.

Why is insomnia a focus in this study?

Insomnia is very common with depression and can make it harder for people to get better, even with antidepressants. Treating insomnia might help depression too.

How to find out more

Pierre-Alexis GEOFFROY, Pr, med

pierrealexis.geoffroy@aphp.fr +33 1 40 25 62 72 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.