Biosignatures of Latuda for Bipolar Depression

NCT02239094 | Completed Results

• 2 other identifiers: #69546954
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar Depression

Keywords

Bipolar Disorder; depression; Bipolar depression

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline

• 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).

  Week 8

Study Arms (1)

Lurasidone (Latuda)

OTHER

All study participants will receive open-label Latuda.

Drug: Lurasidone (Latuda)

Interventions

Lurasidone (Latuda) DRUG

Antipsychotic medication approved for use with Bipolar disorder

Also known as: Latuda

Lurasidone (Latuda)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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)
• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 35377567 DERIVED

Related Links

• Depression Evaluation Service (site location) website
• Institutional department website

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

No healthy volunteer group and no placebo comparisons. And this is an open label treatment study.The results are also limited by the sample size.

Results Point of Contact

• Title: David J. Hellerstein
• Organization: Depression Evaluation Service (New York State Psychiatric Institute)

david.hellerstein@nyspi.columbia.edu

646-774-8069

Study Officials

• Patrick J McGrath, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: September 12, 2014
• Study Start: January 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 12, 2017
• Results First Posted: November 13, 2017

Record last verified: 2017-11

Locations

US (1)