Phase 4 N=1 Basic Science

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

Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT03902613 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Montgomery Asberg Depression Rating Scale — 34 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Lurasidone (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Montgomery Asberg Depression Rating Scale	34	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03902613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.