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

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902613
• Other study ID #: 7673
• Status: Completed
• Phase: Phase 4
• Start date: February 7, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: November 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder

Intervention

Drug:
• Lurasidone
Participant will have an open label trial of lurasidone for eight weeks.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes