Bipolar Depression
Conditions
Keywords
Bipolar Disorder, depression, Bipolar depression
Brief summary
The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.
Detailed description
The study proposes to enroll 20 participants with a bipolar disorder who are currently in an episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical activity (EEG), and psychological testing to explore possible predictors of lurasidone treatment response will be conducted. Blood samples will be collected for a future study of blood protein predictors of response. After testing, participants will receive an open-label 8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain remission of their major depressive episode will be eligible for a six-month continuation phase to explore predictors of sustained response to continuation treatment. Data analyses will use statistical testing to explore potential biological predictors of lurasidone response. This will provide a framework for clarifying which patients are best suited to this treatment and begin to develop a model for precision treatment of this difficult-to-treat disorder.
Interventions
Antipsychotic medication approved for use with Bipolar disorder
Sponsors
Sumitomo Pharma America, Inc.
New York State Psychiatric Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18- 60 2. Outpatients with a primary Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition (DSM-IV) diagnosis of Bipolar Disorder I, II, or NOS (Not Otherwise Specified) 3. Current episode of Major Depression 4. At least moderate severity of depression 5. Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing, magnetic resonance imaging (MRI), and blood draws 6. Provides informed consent
Exclusion criteria
1. Current drug or alcohol abuse/dependence, except nicotine (within 6 months for dependence; 2 for abuse) 2. Taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressant medications, medications with significant interactions with lurasidone, except during the washout prior to testing and blood collection 3. Unstable medical condition, including significant liver disease, hypothyroidism (i.e., condition not adequately stabilized for 3 months), and conditions likely to require hospitalization or with a life expectancy of \< 6 mos.\* 4. Patients considered at significant risk for suicide 5. Inadequate understanding of English 6. Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods; plan to become pregnant within 12 months 7. Contraindications to MRI (e.g. ferromagnetic body implants, history of metal working, etc.) 8. Have epilepsy, neuromuscular disorder, or tardive dyskinesia 9. Require immediate hospitalization for psychiatric disorder 10. Require medications for a general medical condition that contraindicate any study medication\*\* 11. Receiving or have received during the index episode vagus nerve stimulation, electroconvulsive therapy, transcranial magnetic stimulation, or other somatic treatments 12. Allergy to, or other medical contraindication to lurasidone treatment 13. Currently enrolled in another research study, and participation in that study contraindicates participation 14. Clinically significant screening laboratory abnormalities (\* see below) 15. Currently taking an effective mood stabilizer and/or antidepressant regimen 16. Inability to undergo a three week medication-free period, including history of significant clinical deterioration from past periods off medication or when medication dosage was reduced, including mania, severe depression, etc. 17. Any reason not listed herein that would make participation in the study hazardous \*Medical criteria for exclusion: * Untreated hypertension: \> 140/90 Torr on repeated measurement (If hypertension becomes stabilized, subject may enroll in study) * Hepatitis: any liver function test \> 2x the upper limit of normal * Renal failure: estimated Glomerular Filtration Rate (eGFR, corrected for body surface area) repeatedly \< 30 mL/min * Hypothyroidism: thryrotropin stimulating hormone level \> upper limit of normal (unless accompanied by other euthyroid indices and the confirmation by an internist or endocrinologist that this does not represent hypothyroidism) * Anemia: hemoglobin \< 10 grams/deciliter (borderline hemoglobin must be of known origin, stable, and not clinically significant)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Rating Scale for Depression (MADRS) | Baseline | The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). |
| Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8 | Week 8 | The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lurasidone (Latuda) All study participants will receive open-label Latuda.
Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Remitted before started | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lurasidone (Latuda) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 33.4 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 8 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Montgomery-Asberg Rating Scale for Depression (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone (Latuda) | Montgomery-Asberg Rating Scale for Depression (MADRS) | 24.3 units on a scale | Standard Deviation 6.4 |
Primary
Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).
Time frame: Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lurasidone (Latuda) | Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8 | 8 units on a scale | Standard Deviation 8.2 |