Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)

Sumitomo Pharma America, Inc.348 enrolled

Overview

This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of patients with bipolar I depression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

348

Conditions

Bipolar Depression

Interventions

lurasidone + (lithium or divalproex)DRUG

lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.

Placebo + (lithium or divalproex)DRUG

20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is diagnosed with bipolar I disorder, most resent episode depressed * Subject must have a lifetime history of at least one bipolar manic or mixed episode * Subject must be taking lithium or divalproex at least 28 days prior to screening Exclusion Criteria: * History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode * Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization * Imminent risk of suicide or injury to self, others, or property

Locations (71)

Outcomes

Primary Outcomes

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)

MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Time frame: Baseline, Week 6

Secondary Outcomes

Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)

CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Time frame: Baseline Week 6

Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score

STS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.

Time frame: Baselin Week 6

Data from ClinicalTrials.gov

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...and 61 more locations