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

NCT03902613 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 7673
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Lurasidone

EXPERIMENTAL

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

Drug: Lurasidone

Interventions

Lurasidone DRUG

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

Lurasidone

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Martin Lan
• Organization: Columbia University Irving Medical Center

martin.lan@nyspi.columbia.edu

646 774 7610

Study Officials

• Martin Lan, MD PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry at CUMC

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: February 7, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 13, 2023
• Results First Posted: October 6, 2020

Record last verified: 2023-11

Locations

US (1)