18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder

New York State Psychiatric Institute1 enrolled

Overview

The goal of this project is to understand what causes bipolar disorder and how medications treat bipolar depression. Particularly, the project focuses on the importance of dopamine signaling in the process. Participants will have two different brain scans (MRI and PET scan). They will also have treatment for your depression with an FDA approved medication, lurasidone (Latuda). The study is funded by the Columbia University Irving Institute to improve the treatment of bipolar disorder.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Bipolar Depression

Interventions

LurasidoneDRUG

Participant will have an open label trial of lurasidone for eight weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Bipolar I disorder, bipolar II disorder or other specified bipolar disorder * Currently in a major depressive episode and moderately depressed * Age 18-50 years old * Patients on psychiatric medications will not be benefitting from those medications * Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study Exclusion Criteria: * Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa * Previous failed trial of lurasidone, or had intolerable side effects of lurasidone * Significant active physical illness * Actively suicidal * ECT within the past 6 months * Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating * Metal in the body that is not MRI compatible * Current, past or anticipated exposure to radiation * Currently taking an anticoagulant medication

Locations (1)

Columbia University Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Montgomery Asberg Depression Rating Scale

Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome.

Time frame: 15 minutes

Data from ClinicalTrials.gov

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