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NCT Number: NCT07806227

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

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.

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Key information

Conditions

Bipolar Disorder Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of bipolar disorder
  • Having symptoms of depression
  • Taking less than three medications for bipolar disorder

Exclusion criteria

  • 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
  • Any psychotic symptoms that have occurred outside of a mood episode
  • Any electroconvulsive therapy (ECT) within the last six months
  • Currently pregnant or planning to become pregnant during the time of the study

Treatment and study plan

Lurasidone (Latuda)

Drug

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

Primary outcomes

  1. Bipolar Depression Rating Scale

    Time frame: 6 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Martin Lan

CONTACT

[email protected]

646 774 7610

Sponsors and collaborators

Lead sponsor

Martin Lan

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Broadband Near Infrared Spectroscopy to Elucidate the of Role Cortical Brain Cytochrome C Oxidase Activity in the Pathophysiology of Bipolar Disorder

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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