Broadband Near Infrared Spectroscopy to Understand the Role of Brain Cytochrome C Oxidase in Bipolar Disorder

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMartin Lan

About this trial

People with a diagnosis of bipolar disorder who are depressed will have a light-based imaging of the brain (Near Infrared Spectroscopy) before and after they have treatment for their depression with a standard, approved medication named lurasidone. They will also answer questions about their history, and give blood samples. The goal is to understand the role of mitochondrial activity in bipolar disorder. Healthy volunteers who have never had a psychiatric disorder will have the same procedures, but they will not receive the medication.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of bipolar disorder

Having symptoms of depression

Taking less than three medications for bipolar disorder

Disqualifiers

Taking any medications that cannot be combined with lurasidone

Any medical problems that are not well treated

Any drug or alcohol use disorders that are moderate or severe

Any severe suicidal ideation, or having had a suicide attempt in the last five years

Trial design

Design model

Single group

Treatments tested in this trial

  • Lurasidone (Latuda)

    Drug

    The medication will be used to understand how the imaging signal changes when symptoms change during treatment.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Bipolar DisorderExperimental treatment 1 intervention
Group B: Healthy VolunteerNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Bipolar Depression Rating Scale

A measure of depression severity. Higher numbers indicate more symptoms.

Time frame
6 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Martin Lan

Lead sponsor

New York State Psychiatric Institute

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: