18F-DOPA PET to Elucidate the Antidepressant Mechanism of Lurasidone in Bipolar Disorder
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
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
- 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
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.- 7673
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
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
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 |
martin.lan@nyspi.columbia.edu |
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