Biosignatures of Latuda for Bipolar Depression
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lurasidone (Latuda)
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar Disorder, depression, Bipolar depression
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lurasidone (Latuda)
Arm Description
All study participants will receive open-label Latuda.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02239094
First Posted
September 9, 2014
Last Updated
November 13, 2017
Sponsor
New York State Psychiatric Institute
Collaborators
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02239094
Brief Title
Biosignatures of Latuda for Bipolar Depression
Official Title
Identification of Biosignatures for Lurasidone (Latuda) Response in Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar Disorder, depression, Bipolar depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lurasidone (Latuda)
Arm Type
Other
Arm Description
All study participants will receive open-label Latuda.
Intervention Type
Drug
Intervention Name(s)
Lurasidone (Latuda)
Other Intervention Name(s)
Latuda
Intervention Description
Antipsychotic medication approved for use with Bipolar disorder
Primary Outcome Measure Information:
Title
Montgomery-Asberg Rating Scale for Depression (MADRS)
Description
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
Title
Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J McGrath, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35377567
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.
Results Reference
derived
Links:
URL
http://www.depression-nyc.org
Description
Depression Evaluation Service (site location) website
URL
http://columbiapsychiatry.org/
Description
Institutional department website
Learn more about this trial
Biosignatures of Latuda for Bipolar Depression
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