Lurasidone for Bipolar Disorder

ML
Overseen ByMartin Lan
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Martin Lan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

ML

Martin Lan, MD PhD

Principal Investigator

Research Foundation for Mental Hygiene, Inc.

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with bipolar disorder who are currently experiencing depression. Healthy volunteers without any history of psychiatric disorders can also participate, but they will not receive the medication.

Inclusion Criteria

I have been diagnosed with bipolar disorder.
I have symptoms of depression.
I take fewer than three medications for bipolar disorder.

Exclusion Criteria

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
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • Lurasidone

Trial Overview

Researchers are using a brain imaging technique (Near Infrared Spectroscopy) to study changes before and after treatment with lurasidone, an approved medication for bipolar depression. Healthy volunteers undergo the same scans but do not take the drug.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Bipolar DisorderExperimental Treatment1 Intervention
Group II: Healthy VolunteerActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Martin Lan

Lead Sponsor

Trials
1
Recruited
3+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+