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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Alentis Development STRASBOURG, Alsace France
Gehodi Holjpehwjfp Urvrwrwlhwews Pqfzj Pkiyanxlyej Eu Nhhwbjybmzle Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.03.2025

Trial locations

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.

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 ID:
2024-516371-32-00
Protocol code:
APHP230869
Trial Phase:
Therapeutic confirmatory (Phase III)

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