Lurasidone and Cognition in Bipolar I Disorder

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: Lurasidone

• Registration Number: NCT02147379
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Primary Completion: 2015-10
• Study Completion: 2017-01-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. All patients must be taking either lithium or valproate or one of the atypical antipsychotics for mood stabilization.
2. 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.
3. Males or females aged 19 to 65 years inclusive.
4. Diagnostic and Statistical Manual IV edition (DSM-IV TR) diagnosis of Bipolar Type I Disorder, with or without a history of psychosis.
5. Clinically stable with a Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) score less than or equal to 8.
6. A sufficient level of English using a language screening questionnaire.
7. Capability of understanding, consenting to, and complying with the requirements of the study.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cognitive Change in Bipolar I disorder after treatment with Lurasidone	6 weeks	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.

Trial Locations

Locations (1)

University of British Columbia, Department of Psychiatry; 🇨🇦 Vancouver, British Columbia, Canada