Back to results18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lurasidone
Sponsored by
About this trial
This is an interventional basic science trial for Bipolar Depression
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
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lurasidone
Arm Description
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
Outcomes
Primary Outcome Measures
Montgomery Asberg Depression Rating Scale
Measures severity of depression symptoms; Scale from 0 to 54 with higher values associated with greater depression severity
Secondary Outcome Measures
Full Information
NCT ID
NCT03902613
First Posted
April 2, 2019
Last Updated
September 14, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT03902613
Brief Title
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Official Title
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lurasidone
Arm Type
Experimental
Arm Description
Open-label treatment with lurasidone within the dose range of 20-60 mg daily
Intervention Type
Drug
Intervention Name(s)
Lurasidone
Intervention Description
Participant will have an open label trial of lurasidone for eight weeks.
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Description
Measures severity of depression symptoms; Scale from 0 to 54 with higher values associated with greater depression severity
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Lan, MD PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
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