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Melatonin + Sleep Intervention for Bipolar Disorder

Phase 2

Recruiting

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)

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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