Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
- 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
- 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
- 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
Group Intervention Description Lurasidone lurasidone + (lithium or divalproex) - Placebo Placebo + (lithium or divalproex) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Score Baselin 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.
Related Research Topics
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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
Scroll for more (61 remaining)Woodland International Research Inc.🇺🇸Little Rock, Arkansas, United States