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A Study Comparing Melatonin versus Placebo for Mood Stabilization in Patients with Bipolar Disorder

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What is this study about?

This study is looking at bipolar disorder, which is a mental health condition where people experience significant changes in mood, energy, and activity levels. These mood changes can range from very high, energetic periods to very low, depressed periods. The treatment being tested is melatonin, a substance that is naturally produced in the body and helps regulate sleep and wake cycles. In this study, melatonin will be compared to placebo to see which works better. People in the study will continue taking their regular medications and will add either melatonin or placebo to their treatment.

The purpose of this study is to find out if melatonin can help improve mood stability in people with bipolar disorder and whether it can help prevent mood episodes from coming back. The study will also look at whether melatonin helps with symptoms of mania, which are the high-energy periods, or depression, which are the low-energy periods. The study will last for six months, during which participants will take either melatonin or placebo tablets by mouth. The maximum daily dose of melatonin used in the study will be 6 milligrams.

During the study, participants will track their daily mood changes using a digital monitoring system to measure mood stability. Other aspects of health will also be measured, including depression symptoms, sleep quality, mania symptoms, daily functioning, thinking abilities, and certain markers in blood, hair, and urine samples that can show levels of stress and inflammation in the body. These measurements will help researchers understand how well melatonin works compared to placebo in managing bipolar disorder.

1 Initial assessment and confirmation

Your diagnosis of bipolar disorder will be confirmed through a structured interview called SCAN. Bipolar disorder is a condition characterized by alternating periods of elevated and depressed mood.

Your eligibility for the study will be verified, including confirmation that you are between 18 and 70 years of age and able to provide informed consent.

2 Beginning of treatment phase

You will be randomly assigned to receive either melatonin or placebo. Melatonin is a hormone that helps regulate sleep cycles. A placebo is an inactive substance that looks identical to the active medication but contains no active ingredient.

The study is double-blinded, which means neither you nor the medical staff will know which treatment you are receiving during the study.

The medication will be provided as tablets for oral use.

If you receive melatonin, the dose will be 3 mg tablets. The specific frequency and timing of administration will be provided to you at the start of treatment.

This treatment will be given in addition to your current medication regimen.

3 Daily mood monitoring

Throughout the study, you will monitor your mood daily using the Monsenso system. This is a digital tool that allows you to track changes in your mood.

The information you provide will help measure mood stabilization, which refers to reducing the day-to-day fluctuations in how you feel.

This daily monitoring will continue for the duration of the 6-month treatment period.

4 Regular assessments

You will complete several assessment tools at scheduled intervals during the study.

The Hamilton D6 assessment measures symptoms of depression.

The Pittsburgh Sleep Quality questionnaire evaluates how well you are sleeping.

The Young Mania Rating Scale assesses symptoms of mania, which are periods of unusually elevated or irritable mood and increased energy.

The Functioning Assessment Short Test examines how bipolar disorder affects your daily activities and social functioning.

The internet-based Cognition Assessment Tool evaluates your cognitive functions, such as memory, attention, and problem-solving abilities.

5 Biological sample collection

Blood samples will be collected to measure inflammation markers. Inflammation markers are substances in the blood that indicate the presence of inflammation in the body.

Hair samples will be collected to measure cortisol levels. Cortisol is a hormone related to stress.

Urine samples will be collected to measure oxidative stress markers. Oxidative stress refers to damage in the body caused by harmful molecules called free radicals.

These samples will be collected at specific time points during the study.

6 Completion of the 6-month treatment period

The treatment phase will last for 6 months.

You will continue taking the assigned medication and completing all monitoring and assessment activities throughout this period.

At the end of the 6 months, final assessments will be conducted.

Who Can Join the Study?

  • You must have bipolar disorder, which is a mental health condition that causes extreme mood swings including emotional highs and lows, confirmed by a special interview called a SCAN interview, which is a detailed conversation with a healthcare professional to assess mental health symptoms
  • You must be between 18 and 70 years old
  • You must be able to speak and write in Danish or English at a level similar to your native language
  • You must be habile, which means you are able to understand information about the study and make your own decision about whether to participate by giving informed consent, which is your voluntary agreement to join the study after understanding what it involves

Who Cannot Join the Study?

  • The study information does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in participating, the research team will evaluate your individual situation to determine if you are eligible
  • General factors that often prevent participation in studies for bipolar disorder (a mental health condition with extreme mood swings between high and low periods) may include other serious medical conditions, pregnancy, or taking medications that could interfere with the study treatment
  • The study will test melatonin (a natural hormone that helps regulate sleep) compared to placebo (an inactive substance with no medication) as an addition to regular treatment

Where you can join this trial?

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Other Sites

Site Name City Country Status
Htnumg Hgcppdga Herlev Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.12.2025

Trial locations

Investigated drugs:

Melatonin is a hormone that your body naturally makes to help control your sleep-wake cycle. In this study, melatonin is being tested as an additional treatment to see if it can help stabilize mood in people with bipolar disorder. The researchers want to find out if melatonin can help reduce manic episodes, improve depressive symptoms, and prevent relapses of the condition.

Placebo is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against melatonin to determine if melatonin has real effects beyond what might happen naturally or from expectation alone.

Investigated diseases:

Bipolar Disorder – Bipolar disorder is a mental health condition characterized by extreme mood swings that include emotional highs and lows. During manic episodes, a person may feel unusually energetic, euphoric, or irritable, and may engage in impulsive behaviors. During depressive episodes, the person experiences sadness, hopelessness, and loss of interest in activities they once enjoyed. The mood changes can affect sleep patterns, energy levels, behavior, and the ability to think clearly. Between episodes, some people may experience periods of stable mood, while others may have ongoing symptoms. The condition involves recurring cycles of these mood episodes that can vary in intensity and duration.

Trial ID:
2025-523549-92-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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