Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
- Registration Number
- NCT01284517
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- Brief Summary
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
- Provide written informed consent and is 18 to 75 years of age inclusive.
- Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
- Has a lifetime history of at least one bipolar manic or mixed manic episode.
- Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
- Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
- Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
- Good physical health on the basis of medical history, physical examination, and laboratory screening.
- Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
- Any chronic organic disease of the CNS (other than Bipolar I Disorder).
- Hospitalization for a manic or mixed episode within the past two months.
- Used investigational compound within past 6 months.
- Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Lurasidone 20-120 mg flexible dose 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 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 to 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 Baseline to week 6 SDS 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 (75)
Clinical Innovations, Inc.
🇺🇸Costa Mesa, California, United States
Clinical Innovations inc.
🇺🇸Santa Ana, California, United States
Collaborative Neuroscience Network
🇺🇸Torrance, California, United States
Clinical Innovations Inc.
🇺🇸Riverside, California, United States
Accurate Clinical Trials
🇺🇸Kissimmee, Florida, United States
Zarzar Psychiatric Associates, PLLC
🇺🇸Raleigh, North Carolina, United States
Vojenska nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Clinical Neuroscience Solutions Inc.
🇺🇸Orlando, Florida, United States
Hopital Louis-H Lafontaine
🇨🇦Montreal, Quebec, Canada
Northwest Behavioral Research Center
🇺🇸Roswell, Georgia, United States
Neuromeda JSC
🇱🇹Kaunas, Lithuania
Centrum zdravia R. B. K. s.r.o.
🇸🇰Bardejov, Slovakia
St. In. Inst of Neurol, Psych, and Narcol of the AMSU
🇺🇦Kharkov, Ukraine
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Summit Research Network (Seattle) LLC
🇺🇸Seattle, Washington, United States
R.K. Yadav Memorial Mental Health & De-addiction Hospital
🇮🇳Jaipur, Rajasthan, India
Mental Health Care & Research
🇮🇳Jaipur, Rajasthan, India
Colorado Clinical Trials Inc.
🇺🇸Highlands Ranch, Colorado, United States
Clintrial, s.r.o.
🇨🇿Praha, Czech Republic
Institute for Behavioral Medicine LLC
🇺🇸Smyrna, Georgia, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Village Clinical Research Inc.
🇺🇸New York, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Medical & Behavioral Health Research
🇺🇸New York, New York, United States
Pillar Clinical Research
🇺🇸Dallas, Texas, United States
FutureSearch Clinical Trials, LP
🇺🇸Dallas, Texas, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Clinical Research Group Edmonton Inc
🇨🇦Edmonton, Alberta, Canada
Pierre-Janet Hospital
🇨🇦Gatineau, Quebec, Canada
Okanagan Clinical Trials
🇨🇦Kelowna, British Columbia, Canada
Psychiatricka ambulance
🇨🇿Brno-mesto, Czech Republic
Hospital Mental de Antioquia
🇨🇴Cali, Colombia
Brain Mind Behavior Neuroscience Research Institute
🇮🇳Vishakhapatnam, Andh Prad, India
Shanti Nursing Home
🇮🇳Kanchanpalli, Aurangabad, Maharashtra, India
Psychiatry Trial s.r.o.
🇨🇿Praha, Czech Republic
SBKS Medical College and Hospital, Brij Psychiatry Hospital
🇮🇳Vadodara, Gujarat, India
Poona Hospital & Research Center
🇮🇳Pune, Mahara, India
K.S. Hegde Medical Academy
🇮🇳Mangalore, Karna, India
Mahatma Ghandi Institute of Medical Sciences
🇮🇳Wardha, Mahara, India
Kohnodai Hospital, National Center for Global Health & Medicine
🇯🇵Ichikawa, Japan
National Hospital Organization Hizen Psychiatric Center
🇯🇵Kanzaki-gun, Japan
Mahendru Psychiatric Center
🇮🇳Kanpur, Uttar Prad, India
Ongata Hospital
🇯🇵Hachioji-shi, Japan
National Center of Neurology & Psychiatry
🇯🇵Kodaira-shi, Japan
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
🇯🇵Takatsuki, Japan
Asakayama General Hospital
🇯🇵Sakai-shi, Japan
Zirmunai Mental Health Center, Public Institution
🇱🇹Vilnius, Lithuania
Bojniciach
🇸🇰Bojnice, Slovakia
FNsP Bratislava, Nemocnica Ruzinov
🇸🇰Bratislava, Slovakia
Psychiatricka ambulancia Mentum s.r.o.
🇸🇰Bratislava, Slovakia
Nemocnica s poliklikou Sv. Barbory
🇸🇰Roznava, Slovakia
Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
🇺🇦Dnipropetrovsk, Ukraine
Seskines Outpatient Clinic, Public Institution
🇱🇹Vilnius, Lithuania
Nemocnica s poliklinikou Liptovsky Milulas
🇸🇰Liptovsky Mikulas, Slovakia
Pro mente sana
🇸🇰Trencin, Slovakia
Ternopil Regional Municipal Dispensary, Narcology Dept.
🇺🇦Ternopil, Ukraine
Zapor. Reg. CI Hospital, Zaporizhzhia SMU
🇺🇦Zaporizhzhya, Ukraine
Centro de Investigacion y Atencion para la Salud Mental
🇨🇴Bogota, Colombia
CISNE - UIC Campo Abierto
🇨🇴Bogota, Colombia
Abhaya Hospital Psychiatry
🇮🇳Bangalore, Karna, India
Chatrapati Shau Maharaj Medical University
🇮🇳Lucknow, Utter Prad, India
Ziegzdriai Mental Hospital, Public Institution
🇱🇹Kaunas, Lithuania
Silutes Mental Health & Psychtherapy Center, JSC
🇱🇹Silute, Lithuania
Hospital Nacional Arzobispo Loayza
🇵🇪Lima, Peru
Clinica Vesalio
🇵🇪Lima, Peru
PsychoLine s.r.o.
🇸🇰Rimavska Sobota, Slovakia
Lviv Regional Clinical Psychiatric Hospital
🇺🇦Lviv, Ukraine
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
🇨🇴Barranquilla, Colombia
Kyiv City Psychoneurological Hospital #2
🇺🇦Kyiv, Ukraine
Hospital Nacional Hipolito Unanue
🇵🇪Lima, Peru
Kherson Regional Psychiatric Hospital
🇺🇦Kherson, Vil Stepanivka, Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
🇺🇦Dnipropetrovsk, Ukraine