Bipolar Depression
Conditions
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.
Interventions
DRUGLurasidone
Participant will have an open label trial of lurasidone for eight weeks.
Sponsors
Columbia University
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | 15 minutes | Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Lurasidone |
|---|---|
| Age, Continuous | 46 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Montgomery Asberg Depression Rating Scale
Measures severity of depression symptoms; Scale from 0 to 54; higher numbers mean greater depression severity, so a decrease in score is a better outcome.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lurasidone | Montgomery Asberg Depression Rating Scale | 34 units on a scale |