Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

Bipolar I Disorder Clinical Trial

— PERSIST  

Official title:

A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358357
• Other study ID #: D1050296
• Secondary ID: 2011-000986-10
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2011
• Last updated: April 6, 2015
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyChile: Instituto de Salud Pública de ChileCroatia: Ministry of Health and Social CareCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Hungary: National Institute of PharmacyPoland: The Central Register of Clinical TrialsRussia: Ministry of Health of the Russian FederationSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlJapan: Pharmaceutical and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

Description:

This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Open-label Phase

• 18 years of age or older

• Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder

•= 1 manic, mixed manic, or depressed episode in past 2 years

• YMRS or MADRS total score = 14 if on lithium or divalproex; = 18 if not on lithium or divalproex

Double-blind Phase

Inclusion Criteria:

• Subjects must achieve consistent clinical stability, defined as total scores = 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization

Exclusion Criteria:

Open Label Phase

• Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening

• Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached

• Ultra-fast rapid cycling (defined as = 8 mood episodes over the previous 12-month period)

• Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study

• Unstable/inadequately treated medical illness

• The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)

Double Blind Phase

• Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase

• Subjects who have not stabilized during the open-label phase (within 20 weeks)

• Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• Lurasidone
Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
• Placebo
20-80 mg flexible dose

Locations

Country	Name	City	State
Argentina	Centro de Neuropsiquiatria	Buenos Aires
Argentina	IPEM-Instituto de Prevención de las Enfermedades Mentales.	Buenos Aires
Argentina	Novain Neurociencias Group	Buenos Aires
Argentina	Instituto DAMCI	Cordoba
Argentina	Sanatorio Morra	Cordoba	Provincia de Cordoba
Argentina	Clinica Privada de Salud Mental Santa Teresa de Avila	La Plata
Argentina	Centro de Psiquiatria Biologica	Mendoza
Argentina	Centro de Atencion E Invest. Clinica (CAICI)	Rosario	Santa Fe
Australia	The Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Hollywood Medical Centre	Fremantle	Western Australia
Australia	RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria	Malvern	Victoria
Australia	The Melbourne Clinic	Richmond	Victoria
Bulgaria	Psychiatry Dispensary	Bourgas
Bulgaria	University Multiprofiled Hospital for Active Treatment "Sveti Georgi"	Plovdiv
Bulgaria	Regional Psychiatric Dispensary	Rousse
Bulgaria	Multiprofiled Hospital for Active Treatment "Alexandrovska"	Sofia
Bulgaria	Psychiatric Clinic, Military Medical Academy	Sofia
Bulgaria	Multprofiled Hospital for Active Treatment "Sveta Marina"	Varna
Chile	CETEP	Santiago
Chile	Clinica Las Condes	Santiago
Chile	Psicomedica	Santiago
Croatia	Clinic Hospital Centre Rijeka Clinic for Psychiatry	Rijeka
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Croatia	Klinicki Bolnicki Centar Zagreb-Rebro	Zagreb
Croatia	University Hospital Sestremilosrdnice	Zagreb
Croatia	University Hospital Centre Zagreb	Zagreg
Czech Republic	Saint Anne s.r.o.	Brno
Czech Republic	Fakultni Nemocnice Brno	Brno-Bohunice
Czech Republic	Psychiatricka ambulance	Havirov
Czech Republic	Psychiatricka Iecebna U Honzicka	Pisek
Czech Republic	Psychiatricka Ambulance	Prague
Czech Republic	Psychiatricke Centrum Praha	Prague 8-Bohunice
Czech Republic	Clintrial s.r.o.	Praha 10
Czech Republic	Psychiatricka ambulance Prosek	Praha 3
Czech Republic	Psychiaricka ambulance	Praha 4
Czech Republic	Psychosocialni Centrum	Prerov
Czech Republic	Psychiatricka ambulance	Usti nad labem
France	CHS La Chartreuse-Pole 6	Dijon cedex
France	Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique	Dole
France	Hopital Lapeyronie	Montpellier Cedex 5
France	CHRU de Nimes, Service de Psychiatrie adulte	Nimes Cedex 09
Hungary	Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria	Budapest
Hungary	Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz	Budapest
Hungary	Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika	Budapest
Hungary	Nyiro Gyula Korhaz	Budapest
Hungary	Obudai Egeszsegugyi Centurm Kft.	Budapest
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz	Gyula
Japan	Okehazama Hospital Fujita Kokoro Care Center	Aichi
Japan	Ongata Hospital	Hachioji, Tokyo
Japan	National Hospital Organization Hizen Psychiatric Center	Kanzaki	Saga
Japan	Nishigahara Hospital	Kita-ku	Tokyo
Japan	Nagano Prefectural Mental Wellness Center-Komagane	Komagane,	Nagano
Japan	Yuge Hospital	Kumamoto
Japan	Shonan Hospital	Matsumoto-shi	Nagano
Japan	Arakaki Hospital	Okinawa
Japan	Asakayama General Hospital	Sakai	Osaka
Japan	Sapporokousetsu Hospital	Sapporo	Hokkaido
Japan	Goryokai Medical Corporation	Sapporo-shi	Hokkaido
Japan	Haruna Hospital	Shibukawa	Gunma
Japan	Kawada Hospital	Toyama
Poland	NZOZ Syntonia	Gdynia
Poland	NZOZ BioMed	Kielce
Poland	Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu	Torun
Poland	Prywatny Gabinet Lekarski Jaroslaw Strzelec	Tuszyn
Poland	Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy	Wroclaw
Russian Federation	State Healthcare and Forensic Psychiatric Expertise Institution	Izhevsk
Russian Federation	Nizhny Novgorod Regional State Institution of Healthcare	Nizhniy Novgorod
Russian Federation	St Petersburg State Government Healthcare Institution	St. Petersburg
Russian Federation	St. Petersburg State Healthcare Institution (SPSHI)	St. Petersburg
Russian Federation	St.Petersburg State Healthcare Institution (SPSHI)	St. Petersburg
Russian Federation	Mental Health Research Institute of Rams	Tomsk
Serbia	Clinical Centre of Serbia	Belgrade
Serbia	Clinical Hospital Centre Dragisa Misovic	Belgrade
Serbia	Psychiatric Clinic Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Centre Nis	Nis
Serbia	Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"	Novi Knezevac
Slovakia	Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava	Rimavska Sobota
Slovakia	Psychiatricka ambulancia	Zlate Moravce
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Florida Clinical Research LLC	Bradenton	Florida
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center	Dallas	Texas
United States	Harmonex Neuroscience Research	Dothan	Alabama
United States	Charak Center for Health and Wellness	Garfield Heights	Ohio
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	ActivMed Practices & Research Inc.	Haverhill	Massachusetts
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Lincoln Research	Lincoln	Rhode Island
United States	AXIS Clinical Trials	Los Angeles	California
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Galiz Research	Miami Springs	Florida
United States	Village Clinical Research Inc,	New York	New York
United States	Excell Research, Inc.	Oceanside	California
United States	Cutting Edge Research Groupd	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Stanford University School of Medicine Research Program VA Palo Alto Health Care System	Palo Alto	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	SF-CARE, Inc.	San Francisco	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	Psych Care Consultants Research	St. Louis	Missouri
United States	"Stanford University School of Medicine	Stanford	California
United States	Clinco	Terre Haute	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Chile,  Croatia,  Czech Republic,  France,  Hungary,  Japan,  Poland,  Russian Federation,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recurrence of mood event during the double blind treatment phase		28 weeks	No
Secondary	Time to all-cause discontinuation		28 weeks	No
Secondary	Time to recurrence of a manic, mixed manic, hypomanic, or depressed episode		28 weeks	No
Secondary	Proportion of subjects who experience a recurrence of a manic, mixed manic, hypomanic, or depressed episode		28 weeks	No
Secondary	Change from double-blind phase baseline to endpoint in global severity (CGI-B, severity of Illness score) YMRS, MADRS, QIDS - SR16 total score and PANSS-P		28 Weeks	No
Secondary	Subject self-report of functional impairment associated with symptoms of bipolar disorder, assessed by the Sheehan Disability Scale (SDS) total score and SDS subscales		28 Weeks	No
Secondary	Quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionaire-Short Form (Q-LES-Q-SF)		28 Weeks	No
Secondary	Sleep Quality assessed by the Pittsburgh Insomnia Rating Scale (PIRS-2)		28 Weeks	No
Secondary	Health outcome measures: Health Services Utilization Questionaire (HSUQ) and the SF-12 Health Survey		28 Weeks	No
Secondary	Medication Satisfaction Questionaire (MSQ)		28 Weeks	No
Secondary	Proportion of subjects with adverse events (AEs), discontinuation due to AEs, and serious AEs (SAEs)		28 Weeks	Yes
Secondary	Columbia Suicide Severity Rating Scale (C-SSRS, physical examination results		28 Weeks	Yes
Secondary	Weight, laboratory measures, vital signs, and electrocardiograms (ECGs)		28 Weeks	Yes
Secondary	Movement disorders, as assessed by Abnormal Involuntary Movement Scale(AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS)		28 Weeks	Yes
Secondary	Physical Examination		28 Weeks	Yes