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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07806227

Enrollment

Registered

2026-09-08

Start date

2026-11-01

Completion date

2028-07-30

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder Depression

Keywords

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

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.

Interventions

DRUGLurasidone (Latuda)

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bipolar Depression Rating Scale	6 weeks	A measure of depression severity. Higher numbers indicate more symptoms.

Countries

United States

Contacts

CONTACTMartin Lan

martin.lan@nyspi.columbia.edu646 774 7610

PRINCIPAL_INVESTIGATORMartin Lan, MD PhD

Research Foundation for Mental Hygiene, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026