Status:
COMPLETED
Biosignatures of Latuda for Bipolar Depression
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-60 years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- Age 18- 60
- 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)
- Current episode of Major Depression
- At least moderate severity of depression
- Agrees to, and is eligible for, electroencephalogram (EEG) / psychological testing, magnetic resonance imaging (MRI), and blood draws
- Provides informed consent
Exclusion
- Current drug or alcohol abuse/dependence, except nicotine (within 6 months for dependence; 2 for abuse)
- 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
- 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.\*
- Patients considered at significant risk for suicide
- Inadequate understanding of English
- Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods; plan to become pregnant within 12 months
- Contraindications to MRI (e.g. ferromagnetic body implants, history of metal working, etc.)
- Have epilepsy, neuromuscular disorder, or tardive dyskinesia
- Require immediate hospitalization for psychiatric disorder
- Require medications for a general medical condition that contraindicate any study medication\*\*
- Receiving or have received during the index episode vagus nerve stimulation, electroconvulsive therapy, transcranial magnetic stimulation, or other somatic treatments
- Allergy to, or other medical contraindication to lurasidone treatment
- Currently enrolled in another research study, and participation in that study contraindicates participation
- Clinically significant screening laboratory abnormalities (\* see below)
- Currently taking an effective mood stabilizer and/or antidepressant regimen
- 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.
- 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)
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02239094
Start Date
January 1 2015
End Date
September 1 2016
Last Update
December 12 2017
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032