Lurasidone and Cognition in Bipolar I Disorder

NCT ID: NCT02147379

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-01-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lurasidone

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

Group Type: EXPERIMENTAL

Lurasidone

Intervention Type: DRUG

Treatment as usual

Patients randomized to this arm will continue their usual treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lurasidone

Intervention Type: DRUG

Other Intervention Names

Latuda

Eligibility Criteria

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.

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. -

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia, Department of Psychiatry

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28185899 (View on PubMed)

Other Identifiers

H14-00290

Identifier Type: -

Identifier Source: org_study_id