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

NCT07806227 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: Pro00094244R21MH142900
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder Depression

Keywords

Bipolar disorder; Antidepressant treatment; Brain Imaging; Depression; Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (1)

• Bipolar Depression Rating Scale

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

  6 weeks

Study Arms (2)

Bipolar Disorder

EXPERIMENTAL

Participants in a major depressive episode will receive standard treatment with lurasidone for six weeks. Doses can be adjusted based on clinical need.

Drug: Lurasidone (Latuda)

Healthy Volunteer

NO INTERVENTION

Healthy Volunteers will have all research procedures, but will not receive medication treatment

Interventions

Lurasidone (Latuda) DRUG

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

Bipolar Disorder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Lan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (4)

• Kato T. Neurobiological basis of bipolar disorder: Mitochondrial dysfunction hypothesis and beyond. Schizophr Res. 2017 Sep;187:62-66. doi: 10.1016/j.schres.2016.10.037. Epub 2016 Nov 10.

  PMID: 27839913 BACKGROUND

• Picard M, McEwen BS. Psychological Stress and Mitochondria: A Systematic Review. Psychosom Med. 2018 Feb/Mar;80(2):141-153. doi: 10.1097/PSY.0000000000000545.

  PMID: 29389736 BACKGROUND

• Holper L, Mann JJ. Test-retest reliability of brain mitochondrial cytochrome-c-oxidase assessed by functional near-infrared spectroscopy. J Biomed Opt. 2018 May;23(5):1-9. doi: 10.1117/1.JBO.23.5.056006.

  PMID: 29766685 BACKGROUND

• Holper L, Lan MJ, Brown PJ, Sublette EM, Burke A, Mann JJ. Brain cytochrome-c-oxidase as a marker of mitochondrial function: A pilot study in major depression using NIRS. Depress Anxiety. 2019 Aug;36(8):766-779. doi: 10.1002/da.22913. Epub 2019 May 21.

  PMID: 31111623 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martin Lan, MD PhD

  Research Foundation for Mental Hygiene, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Lan

CONTACT

646 774 7610; martin.lan@nyspi.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist VI

Model Details: Bipolar participants receive open label treatment with lurasidone (n=30). Healthy volunteers will not receive treatment (n=30).

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)