Biosignatures of Latuda for Bipolar Depression

Completed · Not applicable

Conditions studied: Bipolar Depression

In brief

The study proposes to conduct a pilot study of biological predictors of lurasidone response in bipolar depression.

Key facts

Study ID

NCT02239094

Run by

New York State Psychiatric Institute

People needed

20

Starts

2015-01-01

Expected to finish

2016-09-01

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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