Clinical trial

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

Name
7673
Description
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.
Trial arms
Trial start
2019-02-07
Estimated PCD
2019-08-01
Trial end
2019-08-01
Status
Completed
Phase
Early phase I
Treatment
Lurasidone
Participant will have an open label trial of lurasidone for eight weeks.
Arms:
Lurasidone
Size
1
Primary endpoint
Montgomery Asberg Depression Rating Scale
15 minutes
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}
Updated at
2023-11-13

1 organization

1 product

1 indication

Product
Lurasidone