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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-07

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lurasidone

Open-label treatment with lurasidone within the dose range of 20-60 mg daily

Group Type EXPERIMENTAL

Lurasidone

Intervention Type DRUG

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

Interventions

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Lurasidone

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No