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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "They will also answer questions about their history, and give blood samples."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses light-based brain scans to learn how cells make energy in people with bipolar disorder who are depressed. They will have scans before and after treatment with lurasidone, an approved medicine for depression, and answer health questions and give blood samples. Healthy volunteers who have never had a mental health disorder will have the same tests but will not take the medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have bipolar disorder.
  • Have symptoms of depression.
  • Take fewer than 3 medicines for bipolar disorder.

Who can't join

  • Take any medicines that cannot be used with lurasidone.
  • Have health problems that are not well treated.
  • Have a moderate or severe drug or alcohol use disorder.
  • Have severe thoughts of suicide, or have attempted suicide in the past 5 years.
  • Have had trouble knowing what is real outside of a period of mood symptoms.
  • Have had electroconvulsive therapy (ECT), a treatment using electrical pulses to the brain, in the past 6 months.
  • Are pregnant or plan to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NY