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

Part of paid clinical trials in New York, New York.

Sponsor
Martin Lan
Study ID
NCT07806227
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Bipolar Disorder Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 8, 2026
Start date
Nov 1, 2026
Status verified
Sep 2026
Primary completion
Jul 30, 2028
Completion
Jul 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bipolar Disorder
    Participants in a major depressive episode will receive standard treatment with lurasidone for six weeks. Doses can be adjusted based on clinical need.
  • No Intervention: Healthy Volunteer
    Healthy Volunteers will have all research procedures, but will not receive medication treatment

Primary Outcome Measure

Bipolar Depression Rating Scale [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York State Psychiatric InstituteNew YorkNew York10032-

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