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.
Trial Locations
- Locations (71)
Clintrial, s.r.o.
🇨🇿Praha, Czech Republic
Manobal Med. Research Centre
🇮🇳Lucknow, Uttar Prad, India
Spitalul Clinic Judetean de Urgenta Cluj
🇷🇴Cluj-Napoca, Romania
Bekhterev Scientific Research Psychoneurological Institute
🇷🇺St. Petersburg, Russian Federation
Psychoneurology Dispensary #4
🇷🇺St. Petersburg, Russian Federation
Spandana Nursing Home
🇮🇳Bangalore, Karna, India
Sheth Vadilal Sarabhai General Hospital
🇮🇳Ahmedabad, Gujarat, India
Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
🇷🇴Bucuresti, Romania
Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
🇷🇴Pitesti, Romania
Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
🇷🇴Bucuresti, Romania
Spitalul Clinic de Neurologie si Psihiatrie Oradea
🇷🇴Oradea, Romania
City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
🇷🇺St. Petersburg, Russian Federation
Moscow Medical Academy named I.M. Sechenov
🇷🇺Moscow, Russian Federation
LLC International Medical Centre "SOGAZ"
🇷🇺St. Petersburg, Russian Federation
Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
🇺🇦Donetsk, Ukraine
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mood Disorders Program-UHCMC
🇺🇸Cleveland, Ohio, United States
Midwest Research Group
🇺🇸St. Charles, Missouri, United States
Woodland International Research Inc.
🇺🇸Little Rock, Arkansas, United States
CNRI - San Diego, LLC
🇺🇸San Diego, California, United States
Depression and Anxiety Disorders Research Institue
🇺🇸Tampa, Florida, United States
J. Gary Booker, MD
🇺🇸Shreveport, Louisiana, United States
Synergy Escondido
🇺🇸Escondido, California, United States
Sheppard Pratt Health System,6501 North Charles Street
🇺🇸Baltimore, Maryland, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Capital Clinical Research,5515 Security Lane, Suite 525
🇺🇸Rockville, Maryland, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
BIALBI s.r.o. Psychiatricke oddeleni
🇨🇿Litomerice, Czech Republic
Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
🇺🇸Raleigh, North Carolina, United States
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
🇺🇸Albuquerque, New Mexico, United States
Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
🇮🇳Vijaywada, Andh Prad, India
South Coast Clinical Trials, Inc.
🇺🇸Anaheim, California, United States
Collaborative Neuroscience Network Inc.,12772 Valley View Street
🇺🇸Garden Grove, California, United States
CNRI - Los Angeles LLC,8309 Telegraph Road
🇺🇸Pico Rivera, California, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States
Psychiatricka ambulance
🇨🇿Brno - mesto, Czech Republic
Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
🇮🇳Delhi, India
Lake Charles Clinical Trials LLC,700 Spring Forest Road
🇺🇸Raleigh, North Carolina, United States
Praktyka Lekarska Sensorium S.M.O.
🇵🇱Skorzewo, Poland
FutureSearch Clinical Trials, LLC., 4200 Marathon Blvd., Suite 200
🇺🇸Austin, Texas, United States
Jana Thomsen
🇩🇪Berlin BE, Germany
SV Medical College
🇮🇳Tirupati, Andh Prad, India
Midwest Clinical research Center, One Elizabeth Place, Suite G-3
🇺🇸Dayton, Ohio, United States
Wojewodzki Szpital Brodnowski SP ZOZ
🇵🇱Warszawa, Poland
Dey Clinic
🇿🇦Pretoria, Gauteng, South Africa
Samvedna Hospitals
🇮🇳Ahmedabad, Gujarat, India
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Medical Services Prague s.r.o.
🇨🇿Praha, Czech Republic
R.K. Yadav Memorial Mental Health & De-Addiction Hospital
🇮🇳Jaipur, Rajasthan, India
Zans Ritter, Marcel
🇫🇷Orvault, France
Paarl Medical Centre
🇿🇦Paarl, W. Cape, South Africa
Vereeniging Medi-Clinic
🇿🇦Vereeniging, Free State, South Africa
Sujata Birla Hospital & Research Centre
🇮🇳Nashik, Mahara, India
Clinika
🇿🇦Port Elizabeth, E. Cape, South Africa
Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
🇺🇦Poltava, Ukraine
Catalina Research Institute
🇺🇸Chino, California, United States
American Medical Research, Inc., 1200 Harger Road Suite 415
🇺🇸Oak Brook, Illinois, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Hopital Caremeau, Service de Psychiatrie A
🇫🇷Nimes Cedex, France
Psychiatricka ambulance Prosek
🇨🇿Praha, Czech Republic
Shree Hatkesh Health Foundation
🇮🇳Junagadh, Gujarat, India
Mental Illness Treatment Rehabilitation Foundation (MITR)
🇮🇳Ahmedabad, Gujarat, India
ZOZ Poradnia Zdrowia Psychicznego
🇵🇱Chelmno, Poland
Spitalul Clinic de Neuropsihiatrie Craiova
🇷🇴Craiova, Romania
Russian State Medical University
🇷🇺Moscow, Russian Federation
Cape Trial Centre
🇿🇦Cape Town, W. Cape, South Africa
Odesa Regional Psychoneurological Dispensary
🇺🇦Odesa, Ukraine
CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
🇺🇦Simferopol, Ukraine
Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog
🇺🇦Vinnitsia, Ukraine
American Medical Research Inc.,1200 Harger Road Suite 415
🇺🇸Oak Brook, Illinois, United States