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

Phase 4Not Yet RecruitingNCT07806227

Martin Lan60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar Disorder Depression

Interventions

Lurasidone (Latuda)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bipolar Depression Rating Scale

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

Time frame: 6 weeks