Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
- Registration Number
- NCT00868699
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 505
- 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
- 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 Placebo Placebo - lurasidone low arm lurasidone - lurasidone high arm lurasidone -
- 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 to Week 6 Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.
The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.
- 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 to Week 6 Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.
The CGI depression score ranges from a minimum of 0 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score Baseline to Week 6 Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression.
The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.
The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.
Trial Locations
- Locations (55)
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Mood Disorders Program-UHCMC
🇺🇸Cleveland, Ohio, United States
R.K. Yadav Memorial Mental Health & De-Addiction Hospital
🇮🇳Jaipur, Rajasthan, India
Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
🇺🇦Poltava, Ukraine
American Medical Research Inc.,1200 Harger Road Suite 415
🇺🇸Oak Brook, Illinois, United States
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
🇺🇸Lake Charles, Louisiana, United States
California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
🇺🇸San Diego, California, United States
Florida Clinical Research Center, LLC,3914 State Road 64 East
🇺🇸Bradenton, Florida, United States
Zans Ritter, Marcel
🇫🇷Orvault, France
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
🇮🇳Vijaywada, Andh Prad, India
Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
🇺🇸West Palm Beach, Florida, United States
BIALBI s.r.o., Psychiatricke Oddeleni
🇨🇿Litomerice, Czech Republic
Clintrial, s.r.o.
🇨🇿Praha, Czech Republic
S V Medical College
🇮🇳Tirupati, Andh Prad, India
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Hopital Caremeau, Service de Psychiatrie A
🇫🇷Nimes Cedex, France
Samvedna Hospitals
🇮🇳Ahmedabad, Gujarat, India
Spitalul Clinic Judetean de Urgenta Cluj
🇷🇴Cluj-Napoca, Romania
Vereeniging Medi-Clinic
🇿🇦Vereeniging, Free State, South Africa
Paarl Medical Centre
🇿🇦Paarl, W. Cape, South Africa
Clinika
🇿🇦Port Elizabeth, E. Cape, South Africa
Dey Clinic
🇿🇦Pretoria, Gauteng, South Africa
Spandana Nursing Home
🇮🇳Bangalore, Karna, India
Spitalul Clinic de Neuropsihiatrie Craiova
🇷🇴Craiova, Romania
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
🇷🇺St. Petersburg, Russian Federation
Spitalul Clinic de Urgenta Militar Central
🇷🇴Bucdresti, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
🇷🇴Oradea, Romania
Reg. Psychiatric Hospital
🇺🇦Odessa, Ukraine
Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
🇺🇦Vinnitsia, Ukraine
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
Excell Research, Inc,3998 Vista Way,Suite 100
🇺🇸Oceanside, California, United States
California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
🇺🇸Pico Rivera, California, United States
Sheppard Pratt Health System,6501 North Charles Street
🇺🇸Baltimore, Maryland, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Psychiatricka ambulance
🇨🇿Brno - mesto, Czech Republic
Medical Services Prague s.r.o.
🇨🇿Kolejni 429-5, Praha, Czech Republic
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
🇷🇴Bucuresti, Romania
Seth K M School of P G Medicine & Research
🇮🇳Ahmedabad, Gujarat, India
Sujata Birla Hospital & Research Centre
🇮🇳Nashik, Mahara, India
Manobal Med. Research Centre
🇮🇳Lucknow, Uttar Prad, India
Cape Trial Centre
🇿🇦Cape Town, W. Cape, South Africa
Bekhterev Scientific Research Psychoneurological Institute
🇷🇺St. Petersburg, Russian Federation
CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
🇺🇦Simferopol, Ukraine
Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
🇺🇸Garden Grove, California, United States
Synergy Escondido,710 East Grand Ave.
🇺🇸Escondido, California, United States
Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
🇺🇸Maitland, Florida, United States
Depression and Anxiety Disorders Research Institute
🇺🇸Tampa, Florida, United States
Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
🇺🇸Albuquerque, New Mexico, United States
Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
🇺🇸Raleigh, North Carolina, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States
FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200
🇺🇸Austin, Texas, United States
Chair of Psychiatry and Medical Psychology
🇺🇦Donetsk, Ukraine
Psychoneurology Dispensary #4
🇷🇺St. Petersburg, Russian Federation
University of Colorado
🇺🇸Aurora, Colorado, United States
Mental Illness Treatment Rehabilitationi Foundation
🇮🇳Ahmedabad, Gujarat, India