Health TrialsbyHealthPanel

Correcting Circadian Rhythms to Breakthrough in Bipolar Disorder

ConditionsBipolar DisorderDelayed Sleep-Wake Phase Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLeslie Swanson

About this trial

The purpose of this study is to test whether a dietary supplement (low-dose melatonin) commonly used to treat night owls, administered in conjunction with a behavioral sleep intervention, will help to shift the brain clock earlier and improve mood and sleep in bipolar disorder. Eligible participants will be randomized to receive melatonin plus a behavioral sleep intervention or placebo plus a behavioral sleep placebo.

The hypotheses for this study include:

* Melatonin plus behavioral sleep intervention (compared to placebo plus behavioral sleep placebo) will produce a greater advance of dim light melatonin onset (DLMO), between pre- and post-treatment. * Melatonin (compared to placebo) will produce a greater reduction in Patient Health Questionnaire-9 score between pre- and post-treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Capable of giving informed consent

Meet The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for bipolar disorder (BD) I or II

Evening chronotype per the Morningness-Eveningness Questionnaire (MEQ) defined by a score of <42

At least mild depressive symptoms on the Patient Health Questionnaire (PHQ)-9 defined by a score ≥5

Disqualifiers

Insomnia per DSM-5

Sleep-disordered breathing per Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP-BANG)

Restless leg syndrome per sleep interview

Narcolepsy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Drug

    Participants randomized to this intervention will take 1 oral pill (0.5 milligrams (mg)) daily. They will attend 4 weekly behavioral sleep intervention sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.

  • Placebo

    Other intervention

    Participants randomized to this intervention will take 1 oral placebo pill daily. They will attend 4 weekly behavioral sleep control sessions with a therapist. In addition, participants will complete questionnaires (MyDataHelp app), monitor sleep, collect saliva samples, and wear the Fitbit Device.

  • Behavioral sleep intervention

    Behavioral

    An active intervention that is typically paired with melatonin to maximize treatment effects.

  • Behavioral sleep control

    Behavioral

    A behavioral placebo (which does not improve sleep in delayed sleep-wake phase disorder) to control for social/interpersonal effects of behavioral sleep intervention sessions.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: MelatoninExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Onset of melatonin in dim light conditions as measured in saliva (also called DLMO). Time of DLMO is measured in clock time and change in time of DLMO is measured in hours. The change score is calculated as time at 4 weeks minus baseline time. Thus, positive scores indicate a shift towards a later onset of melatonin and negative scores indicate a shift towards an earlier onset of melatonin.

Time frame
4 weeks (after treatment period)

Secondary outcomes

1

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

The PHQ-9 is a 9-item self-report scale to screen for symptoms of depression. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27, where higher scores indicate more severe depressive symptoms.

Time frame
Baseline, 4 weeks (after treatment period)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Leslie Swanson

Lead sponsor

University of Michigan

Sponsor institution

University of Michigan

Collaborator

Natrol

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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