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Study of Light Therapy and Melatonin for Treatment of Major Depressive Episode with Insomnia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with Major Depressive Episode combined with insomnia. The research examines the effectiveness of two treatments used together or separately: light therapy and melatonin. Melatonin is a naturally occurring hormone that helps regulate sleep patterns, and in this study, it is used as a prolonged-release tablet containing 2 mg of the active substance.

The purpose of this research is to determine how well these treatments work in reducing depression symptoms when used over an 8-week period. During the study, participants will be divided into different groups, with some receiving melatonin, some receiving light therapy, some receiving both treatments, and others receiving placebo. The treatment period lasts for 8 weeks, with regular check-ups to monitor participants' progress.

Throughout the study, doctors will assess changes in depression symptoms and sleep patterns. They will use various methods to measure improvements in mood and sleep quality. The total amount of melatonin that participants might receive during the entire study period is 112 mg, taken as daily doses of 2 mg in the form of prolonged-release tablets.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and randomization

    You will be assessed for major depressive episode and insomnia during the first visit (Week 0)

    You will be randomly assigned to one of four treatment groups

    You will receive either melatonin tablets (2 mg prolonged-release) or placebo tablets

    You will also be assigned to either receive active light therapy or its alternative

  2. Step 2

    Treatment period - Week 1

    You will take the assigned tablet (melatonin or placebo) daily for oral use

    You will follow the prescribed light therapy schedule if assigned to that group

    Your depression symptoms and sleep quality will be evaluated

    You will complete questionnaires about side effects and mood state

    Your sleep patterns will be monitored through activity tracking

  3. Step 3

    Treatment period - Week 4

    Continuation of daily medication and light therapy as prescribed

    Clinical evaluation of your depression symptoms

    Assessment of sleep quality and patterns

    Completion of mood state and side effects questionnaires

    Activity monitoring of sleep-wake patterns

  4. Step 4

    Treatment completion - Week 8

    Final evaluation of depression symptoms

    Assessment of sleep quality and patterns

    Completion of all questionnaires

    Final activity monitoring assessment

    End of medication and light therapy treatment

  5. Step 5

    Follow-up - 3 months

    Final assessment of depression symptoms

    Evaluation of sleep quality

    Completion of mood state questionnaires

    Overall assessment of treatment effectiveness

Who can join the trial?

8 criteria

  • Must be between 18 and 65 years old
  • Must have been diagnosed with Major Depressive Episode (a period of severe depression) and score at least 20 points on the MADRS depression scale, indicating moderate depression
  • Must have sleep problems (insomnia) and score at least 8 points on the ISI sleep scale, showing mild but significant sleep difficulties
  • Must not have taken any antidepressant medications in the past month
  • Must not have undergone any light therapy treatments in the past month
  • Must be able to participate in treatment for 8 weeks, either as an outpatient or while staying in a medical facility
  • Must be able to understand and sign the informed consent form, which explains the study details and patient rights
  • Can be either male or female

Who cannot join the trial?

15 criteria

  • History of bipolar disorder (a condition with alternating periods of depression and elevated mood)
  • Current psychotic symptoms (loss of touch with reality, such as hearing voices or having false beliefs)
  • Recent changes in antidepressant medication within the past 4 weeks
  • Current use of other medications that can affect sleep or mood
  • Shift work or irregular sleep schedules that could interfere with the treatment schedule
  • Severe eye conditions that might be affected by light therapy
  • Known allergies to melatonin or its components
  • Pregnancy or breastfeeding
  • Severe liver or kidney problems that could affect medication processing
  • Current participation in other clinical trials
  • History of seizures or epilepsy
  • Unstable medical conditions that require frequent medication changes
  • History of substance abuse within the past 6 months
  • Severe sleep apnea or other major sleep disorders
  • Unable to follow study procedures or attend regular study visits
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Investigated drugs

  • Light therapy

    is a non-medication treatment that involves exposure to bright artificial light at specific times of the day. It helps regulate the body's natural sleep-wake cycle (circadian rhythm) and is used to treat depression, especially when it's accompanied by sleep problems. The therapy is delivered through a special light box that provides controlled amounts of bright light.

  • Melatonin

    is a hormone naturally produced by the body that helps regulate sleep patterns. As a medication, it is used to help people who have difficulty sleeping and can help adjust the body's internal clock. It may be particularly helpful for people who experience both depression and sleep problems.

What is already known about the treatment

  • Melatonin (prolonged-release)

    A hormone-based medication administered orally in tablet form that helps regulate sleep-wake cycles in the body. This prolonged-release formulation is designed to maintain consistent blood levels throughout the night, making it particularly effective for treating insomnia and sleep disorders associated with depression. The medication works by binding to specific receptors in the brain that control circadian rhythms, helping to establish a normal sleep pattern and improve sleep quality. As a chronotherapeutic agent, it is classified as a sleep-regulating hormone that can be used alongside other treatments for major depressive episodes.

  • Light Therapy

    A non-pharmaceutical treatment method that involves exposure to specific wavelengths of bright light, typically administered through a specialized light box during morning hours. This therapy works by regulating the body's internal clock and suppressing melatonin production during daytime hours, which helps normalize circadian rhythms in patients with depression and sleep disorders. Light therapy influences neurotransmitter systems in the brain, particularly serotonin pathways, making it an effective chronotherapeutic intervention for treating both insomnia and depressive symptoms. The treatment is classified as a non-invasive chronotherapeutic intervention that can be used either alone or in combination with other therapeutic approaches.

Investigated diseases

  • Insomnia

    A sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite having adequate time and opportunity for sleep. People with insomnia often experience poor sleep quality, wake up feeling unrefreshed, and may have trouble functioning during the day. The condition can be short-term or persist for months or longer.

  • Major Depressive Episode

    A period of at least two weeks during which a person experiences persistent feelings of sadness, loss of interest or pleasure in activities, and changes in daily functioning. Common features include changes in sleep patterns, appetite changes, difficulty concentrating, decreased energy, and feelings of worthlessness. The condition affects both emotional and physical well-being, impacting daily activities and social interactions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516371-32-00Protocol codeAPHP230869Estimated enrolment184 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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