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OpenTrials
Completed

NCT Number: NCT03902613

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

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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Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Medical Center

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lurasidone

Drug

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

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Columbia University

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2019
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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