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

Phase 3
Completed
Conditions
Bipolar Depression
Interventions
Drug: Placebo + (lithium or divalproex)
Registration Number
NCT00868452
Lead Sponsor
Sumitomo Pharma America, Inc.
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
348
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lurasidonelurasidone + (lithium or divalproex)-
PlaceboPlacebo + (lithium or divalproex)-
Primary Outcome Measures
NameTimeMethod
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)Baseline, 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.

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

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.

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

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.

Trial Locations

Locations (71)

Woodland International Research Inc.

🇺🇸

Little Rock, Arkansas, United States

South Coast Clinical Trials, Inc.

🇺🇸

Anaheim, California, United States

Catalina Research Institute

🇺🇸

Chino, California, United States

Synergy Escondido

🇺🇸

Escondido, California, United States

Collaborative Neuroscience Network Inc.,12772 Valley View Street

🇺🇸

Garden Grove, California, United States

Cedars-Sinai Medical Center

🇺🇸

Los Angeles, California, United States

University of California at Irvine Medical Center

🇺🇸

Orange, California, United States

CNRI - Los Angeles LLC,8309 Telegraph Road

🇺🇸

Pico Rivera, California, United States

CNRI - San Diego, LLC

🇺🇸

San Diego, California, United States

Stanford University School of Medicine

🇺🇸

Stanford, California, United States

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Woodland International Research Inc.
🇺🇸Little Rock, Arkansas, United States

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