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

Phase 4

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: Lurasidone

• Registration Number: NCT03902613
• Lead Sponsor: New York State Psychiatric Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-07
• Study First Submitted: 2019-04-02
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Results First Submitted: 2020-09-14
• Results First Submitted QC: 2020-09-14
• Results First Posted: 2020-10-06
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lurasidone	Lurasidone	Open-label treatment with lurasidone within the dose range of 20-60 mg daily

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale	15 minutes	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States