Lurasidone and Cognition in Bipolar I Disorder

NCT02147379 | Completed Phase 3

• 1 other identifier: H14-00290
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I disorder (manic depression), who are in remission from an episode. Participants who show cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on to their current medication(s) or continue their usual treatment for 6 weeks. Participants will have 3 clinical visits and 2 telephone appointments during the study. Given the preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.

Conditions

Bipolar I Disorder

Keywords

Bipolar Disorder; Cognition; Euthymic; Lurasidone

Outcome Measures

Primary Outcomes (1)

• Cognitive Change in Bipolar I disorder after treatment with Lurasidone

  The International Society for Bipolar Disorders-Battery for Assessment of Neurocognition (ISBD-BANC) will be administered to assess cognitive functioning at baseline and at endpoint ( change in scores on cognitive tests) to evaluate the efficacy of lurasidone on cognitive changes in bipolar disorder.

  6 weeks

Study Arms (2)

Lurasidone

EXPERIMENTAL

Lurasidone 20 - 80 mg / day added to current treatment for 6 weeks.

Drug: Lurasidone

Treatment as usual

NO INTERVENTION

Patients randomized to this arm will continue their usual treatment.

Interventions

Lurasidone DRUG

Also known as: Latuda

Lurasidone

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization.
• Patients who show cognitive impairments (-0.25 standard deviations (SD) or below) on either the Trail Making Test- trial B (TMT-B) or California Verbal Learning Test (CVLT) trials 1 to 5, or CVLT long delay free recall, at baseline visit.
• Males or females aged 19 to 65 years inclusive.
• Diagnostic and Statistical Manual IV edition (DSM-IV TR) diagnosis of Bipolar Type I Disorder, with or without a history of psychosis.
• Clinically stable with a Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8.
• A sufficient level of English using a language screening questionnaire.
• Capability of understanding, consenting to, and complying with the requirements of the study.

You may not qualify if:

• A history of unstable or inadequately treated medical illnesses, including moderate to severe brain injury, or neurological illnesses impacting cognitive function.
• Treatment with Electroconvulsive Therapy (ECT) within eight weeks prior to enrolment; or treatment with an experimental drug within 30 days prior to enrolment.
• Axis I diagnosis of substance abuse or dependence within the past month.
• Significant risk of harm to self or others, in the opinion of the investigator.
• Pregnancy or lactation in female subjects.
• Liver function tests (AST and ALT) three times the upper limit of normal. -

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Publications (1)

• Yatham LN, Mackala S, Basivireddy J, Ahn S, Walji N, Hu C, Lam RW, Torres IJ. Lurasidone versus treatment as usual for cognitive impairment in euthymic patients with bipolar I disorder: a randomised, open-label, pilot study. Lancet Psychiatry. 2017 Mar;4(3):208-217. doi: 10.1016/S2215-0366(17)30046-9. Epub 2017 Feb 7.

  PMID: 28185899 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lakshmi N Yatham, MBBS,FRCPC,MRCPsych (UK),MB

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 12, 2017
• Last Updated: February 2, 2017

Record last verified: 2017-02

Locations

CA (1)