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

NCT07806227 — Phase 4, Not yet recruiting, 60 participants, Martin Lan

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07806227
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	60 (Estimated)
Sponsor	Martin Lan (Other); collaborators: National Institute of Mental Health (NIMH)
Conditions	Bipolar Disorder Depression
Interventions	Lurasidone (Latuda) (Drug)
Dates	start 2026-11-01 (estimated), primary completion 2028-07-30 (estimated), completion 2028-07-30 (estimated), first posted 2026-09-08, last updated 2026-09-08
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Bipolar Disorder	Experimental	Drug: Lurasidone (Latuda)	Participants in a major depressive episode will receive standard treatment with lurasidone for six weeks. Doses can be adjusted based on clinical need.
Healthy Volunteer	No intervention		Healthy Volunteers will have all research procedures, but will not receive medication treatment

Lurasidone (Latuda) (Drug): The medication will be used to understand how the imaging signal changes when symptoms change during treatment.

+Outcome measures

Primary outcomes

Bipolar Depression Rating Scale [6 weeks]: A measure of depression severity. Higher numbers indicate more symptoms.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
New York State Psychiatric Institute	New York, New York	United States

+Publications

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
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
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
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

+Investigators

Martin Lan, MD PhD, Principal investigator, Research Foundation for Mental Hygiene, Inc.

+Funding

NIH grants: R21MH142900