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

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Completed
CT.gov ID
NCT03902613
Collaborator
Columbia University (Other)
1
1
1
5.7
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
Actual Study Start Date :
Feb 7, 2019
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lurasidone

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

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

Outcome Measures

Primary Outcome Measures

  1. Montgomery Asberg Depression Rating Scale [15 minutes]

    Measures severity of depression symptoms; Scale from 0 to 54 with higher values associated with greater depression severity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • New York State Psychiatric Institute
  • Columbia University

Investigators

  • Principal Investigator: Martin Lan, MD PhD, Columbia University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Martin Lan, Assistant Professor of Psychiatry at CUMC, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT03902613
Other Study ID Numbers:
  • 7673
First Posted:
Apr 4, 2019
Last Update Posted:
Oct 6, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Lurasidone
Arm/Group Description Open-label treatment with lurasidone within the dose range of 20-60 mg daily Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
Period Title: Overall Study
STARTED 1
COMPLETED 0
NOT COMPLETED 1

Baseline Characteristics

Arm/Group Title Lurasidone
Arm/Group Description Open-label treatment with lurasidone within the dose range of 20-60 mg daily Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
Overall Participants 1
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
46
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
1
100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
Not Hispanic or Latino
1
100%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
0
0%
White
1
100%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
1
100%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Lurasidone
Arm/Group Description Open-label treatment with lurasidone within the dose range of 20-60 mg daily Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
Measure Participants 1
Mean (Full Range) [units on a scale]
34

Adverse Events

Time Frame One year
Adverse Event Reporting Description
Arm/Group Title Lurasidone
Arm/Group Description Open-label treatment with lurasidone within the dose range of 20-60 mg daily Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
All Cause Mortality
Lurasidone
Affected / at Risk (%) # Events
Total 0/1 (0%)
Serious Adverse Events
Lurasidone
Affected / at Risk (%) # Events
Total 0/1 (0%)
Other (Not Including Serious) Adverse Events
Lurasidone
Affected / at Risk (%) # Events
Total 0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Martin Lan
Organization Columbia University Irving Medical Center
Phone 646 774 7610
Email martin.lan@nyspi.columbia.edu
Responsible Party:
Martin Lan, Assistant Professor of Psychiatry at CUMC, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT03902613
Other Study ID Numbers:
  • 7673
First Posted:
Apr 4, 2019
Last Update Posted:
Oct 6, 2020
Last Verified:
Sep 1, 2020