Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
PREVAIL3
A Randomized, 6-week Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
2 other identifiers
interventional
356
10 countries
75
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2010
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
October 14, 2013
CompletedNovember 26, 2013
October 1, 2013
1.8 years
January 25, 2011
August 7, 2013
October 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (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.
Baseline to week 6
Secondary Outcomes (2)
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
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Baseline to week 6
Study Arms (2)
Lurasidone 20-120 mg flexible dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (75)
Clinical Innovations, Inc.
Costa Mesa, California, 92647, United States
Clinical Innovations Inc.
Riverside, California, 92506, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Clinical Innovations inc.
Santa Ana, California, 92705, United States
Collaborative Neuroscience Network
Torrance, California, 90502, United States
Colorado Clinical Trials Inc.
Highlands Ranch, Colorado, 80130, United States
Accurate Clinical Trials
Kissimmee, Florida, 34741, United States
Clinical Neuroscience Solutions Inc.
Orlando, Florida, 32806, United States
Northwest Behavioral Research Center
Roswell, Georgia, 30076, United States
Institute for Behavioral Medicine LLC
Smyrna, Georgia, 30080, United States
Precise Research Centers
Flowood, Mississippi, 39232, United States
Village Clinical Research Inc.
New York, New York, 10003, United States
Medical & Behavioral Health Research
New York, New York, 10023, United States
Zarzar Psychiatric Associates, PLLC
Raleigh, North Carolina, 27607, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, 97210, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
FutureSearch Clinical Trials, LP
Dallas, Texas, 75231, United States
Pillar Clinical Research
Dallas, Texas, 75243, United States
Red Oak Psychiatry Associates, PA
Houston, Texas, 77090, United States
Summit Research Network (Seattle) LLC
Seattle, Washington, 98104, United States
Clinical Research Group Edmonton Inc
Edmonton, Alberta, T6L 6W6, Canada
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9, Canada
Pierre-Janet Hospital
Gatineau, Quebec, J9A 1K7, Canada
Hopital Louis-H Lafontaine
Montreal, Quebec, H1N 3M5, Canada
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, Colombia
Centro de Investigacion y Atencion para la Salud Mental
Bogotá, 103, Colombia
CISNE - UIC Campo Abierto
Bogotá, Colombia
Hospital Mental de Antioquia
Cali, Colombia
Psychiatricka ambulance
Brno-mesto, 602 00, Czechia
Vojenska nemocnice Olomouc
Olomouc, 711 11, Czechia
Clintrial, s.r.o.
Prague, 10 100 00, Czechia
Psychiatry Trial s.r.o.
Prague, 158 00, Czechia
Brain Mind Behavior Neuroscience Research Institute
Visakhapatnam, Andh Prad, 530002, India
Shanti Nursing Home
Kanchanpalli, Aurangabad, Maharashtra, India
SBKS Medical College and Hospital, Brij Psychiatry Hospital
Vadodara, Gujarat, 390001, India
Abhaya Hospital Psychiatry
Bangalore, Karna, 560027, India
K.S. Hegde Medical Academy
Mangalore, Karna, 575018, India
Poona Hospital & Research Center
Pune, Mahara, 411 030, India
Mahatma Ghandi Institute of Medical Sciences
Wardha, Mahara, 442102, India
Mental Health Care & Research
Jaipur, Rajasthan, 302017, India
R.K. Yadav Memorial Mental Health & De-addiction Hospital
Jaipur, Rajasthan, 302021, India
Mahendru Psychiatric Center
Kanpur, Uttar Prad, 208005, India
Chatrapati Shau Maharaj Medical University
Lucknow, Utter Prad, 226003, India
Ongata Hospital
Hachioji-shi, 192 0153, 13, Japan
Kohnodai Hospital, National Center for Global Health & Medicine
Ichikawa, 272 8516 12, Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki-gun, 842 0192 41, Japan
National Center of Neurology & Psychiatry
Kodaira-shi, 187 8551 13, Japan
Asakayama General Hospital
Sakaishi, 590 0018, 27, Japan
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
Takatsuki, 569-1041, Japan
Neuromeda JSC
Kaunas, 50185, Lithuania
Ziegzdriai Mental Hospital, Public Institution
Kaunas, 53136, Lithuania
Silutes Mental Health & Psychtherapy Center, JSC
Šilutė, 99142, Lithuania
Seskines Outpatient Clinic, Public Institution
Vilnius, 07156, Lithuania
Zirmunai Mental Health Center, Public Institution
Vilnius, 09112, Lithuania
Hospital Nacional Arzobispo Loayza
Lima, 01, Peru
Hospital Nacional Hipolito Unanue
Lima, 27, Peru
Clinica Vesalio
Lima, 41, Peru
Centrum zdravia R. B. K. s.r.o.
Bardejov, 085 01, Slovakia
Bojniciach
Bojnice, 97201, Slovakia
Psychiatricka ambulancia Mentum s.r.o.
Bratislava, 82007, Slovakia
FNsP Bratislava, Nemocnica Ruzinov
Bratislava, 82606, Slovakia
Nemocnica s poliklinikou Liptovsky Milulas
Liptovský Mikuláš, 03123, Slovakia
PsychoLine s.r.o.
Rimavská Sobota, 97901, Slovakia
Nemocnica s poliklikou Sv. Barbory
Rožňava, 048 01, Slovakia
Pro mente sana
Trenčín, 91101, Slovakia
Kherson Regional Psychiatric Hospital
Kherson, Vil Stepanivka, 73488, Ukraine
Dnipropetrovsk Regional Clinical Hospital named Mechnikov
Dnipropetrovsk, 49005, Ukraine
Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
Dnipropetrovsk, 49115, Ukraine
St. In. Inst of Neurol, Psych, and Narcol of the AMSU
Kharkiv, Ukraine
Kyiv City Psychoneurological Hospital #2
Kyiv, 02660, Ukraine
Lviv Regional Clinical Psychiatric Hospital
Lviv, 79021, Ukraine
Ternopil Regional Municipal Dispensary, Narcology Dept.
Ternopil, 46020, Ukraine
Zapor. Reg. CI Hospital, Zaporizhzhia SMU
Zaporizhzhya, 69032, Ukraine
Related Publications (2)
Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
PMID: 39098761DERIVEDSuppes T, Kroger H, Pikalov A, Loebel A. Lurasidone adjunctive with lithium or valproate for bipolar depression: A placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res. 2016 Jul;78:86-93. doi: 10.1016/j.jpsychires.2016.03.012. Epub 2016 Mar 31.
PMID: 27089521DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, CNS
- Organization
- Sunovion
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Sumitomo Pharma America, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 27, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 26, 2013
Results First Posted
October 14, 2013
Record last verified: 2013-10