Clinical trial NCT02239094: Biosignatures of Latuda for Bipolar Depression
Official title: Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Keywords: Bipolar Disorder
depression
Bipolar depression
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2014-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Montgomery-Asberg Rating Scale for Depression (MADRS)
timeFrame: Baseline
measure: Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Patrick J McGrath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lan MJ, Pantazatos SP, Ogden RT, Rubin-Falcone H, Hellerstein D, McGrath PJ, Mann JJ. Resting State MRI Amplitude of Low Frequency Fluctuations Associated With Suicidal Ideation in Bipolar Depression. J Clin Psychiatry. 2022 Mar 30;83(3):21m14054. doi: 10.4088/JCP.21m14054.