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Melatonin for Bipolar Disorder

Phase 2

Waitlist Available

Led By Leslie Swanson, PhD

Research Sponsored by Leslie Swanson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capable of giving informed consent

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks (after treatment period)

Awards & highlights

Study Summary

This trial is testing whether a dietary supplement called low-dose melatonin, along with a sleep improvement program, can help people with bipolar disorder sleep better and improve their mood. Participants will be randomly assigned

Who is the study for?

This trial is for individuals with Bipolar Disorder who also have trouble sleeping at the right times, like night owls. Participants should be interested in trying a dietary supplement and behavioral sleep techniques to improve their mood and sleep patterns.Check my eligibility

What is being tested?

The study is testing if taking low-dose melatonin along with learning new sleep behaviors can help people with Bipolar Disorder fall asleep earlier and feel better. Half will get real melatonin; the other half gets a fake pill (placebo), both with behavior training.See study design

What are the potential side effects?

Melatonin may cause drowsiness, headache, dizziness or nausea. The behavioral intervention typically doesn't have side effects but could include temporary stress from changing habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks (after treatment period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks (after treatment period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks (after treatment period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in time of Dim Light Melatonin Onset (DLMO) baseline (pre-treatment) to 4 weeks (post-treatment)

Secondary outcome measures

Change in the Patient Health Questionnaire-9 (PHQ-9)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MelatoninExperimental Treatment2 Interventions

Oral medication will be taken for 28 days on the afternoon or evening of the participants first intervention session and continue daily for the remainder of the treatment period.

Group II: PlaceboPlacebo Group2 Interventions

Oral medication will be taken for 28 days on the afternoon or evening of the participants first intervention session and continue daily for the remainder of the treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

2014

Completed Phase 4

~1150

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,783 Previous Clinical Trials

2,689,099 Total Patients Enrolled

145 Trials studying Bipolar Disorder

63,535 Patients Enrolled for Bipolar Disorder

NatrolUNKNOWN

University of MichiganOTHER

1,795 Previous Clinical Trials

6,373,886 Total Patients Enrolled

19 Trials studying Bipolar Disorder

3,162 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to partake in this research investigation?

"To be eligible for this clinical trial, individuals must have a diagnosis of bipolar disorder and fall between the age range of 18 to 60 years old. The study is currently seeking a total of 50 participants."

Answered by AI

Are individuals still eligible to participate in this ongoing research?

"According to the information provided on clinicaltrials.gov, this particular trial is not currently seeking participants. The trial was originally posted on March 1st, 2024 and was last updated on January 16th, 2024. However, it's noteworthy that there are currently 162 other trials actively recruiting participants at this time."

Answered by AI

Is the age criterion for participation in this medical study inclusive of individuals who are 75 years or older?

"The eligibility criteria for this study require potential participants to be above 18 years old and below 60 years old."

Answered by AI

What is the level of safety associated with Melatonin usage in individuals?

"Based on our assessment at Power, the safety of melatonin in this Phase 2 trial is rated as a 2. Although there is some evidence supporting its safety, there is currently no data indicating its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

Leslie Swanson 2024. "Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06226025.

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