This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

Bipolar I Disorder Clinical Trial

— PERSISTExt  

Official title:

A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575561
• Other study ID #: D1050308
• Secondary ID: 2011-004789-14
• Status: Completed
• Phase: Phase 3
• First received: March 28, 2012
• Last updated: August 6, 2015
• Start date: June 2012
• Est. completion date: July 2015

Study information

• Verified date: August 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 PharmacyIndia: Drugs Controller General of IndiaPoland: 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 Control
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Description:

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has agreed to participate by providing written informed consent.

• Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR

• Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR

• Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.

• Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

• Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.

• Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• Lurasidone
Lurasidone 20-80 mg taken orally once daily

Locations

Country	Name	City	State
Argentina	Clinica Privada de Salud Mental Santa Teresa de Avila	Buenos Aires
Argentina	Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)	Buenos Aires
Argentina	Instituto Nacional de Psicopatología (INAPSI)	Buenos Aires
Argentina	Novain Neurociencias Group	Buenos Aires
Argentina	Instituto DAMIC SRL	Cordoba
Argentina	Centro de Investigacion y Asistencia en Psiquiatria (CIAP)	Rosario
Bulgaria	Center for Mental Health	Rousse
Bulgaria	Military Medical Academy	Sofia
Bulgaria	Multiprofiled Hospital for Active Treatment "Alexandrovska"	Sofia
Chile	Clinica Pedro Montt	Santiago
Chile	Hospital El Pino	Santiago
Czech Republic	Saint Anne, s.r.o., Psychiatricke oddeleni	Brno - mesto
Czech Republic	Psychiatricka ambulance	Havirov
Czech Republic	Psychiatricka lecebna U Honzicka	Pisek
Czech Republic	Psychiatricka ambulance	Prague
Czech Republic	Clintrial s.r.o.	Praha
Czech Republic	Psychiatricka ambulance	Praha
Czech Republic	Psychiatricka ambulance Prosek	Praha
Czech Republic	Telemens, s.r.o.	Prerov
France	CHS La Chartreuse - Pôle 6	Dijon cedex
France	Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique	Dole
France	Centre Hospitalier Régional Universitaire	Nimes
Hungary	Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika	Budapest
Hungary	Nyiro Gyula Korhaz	Budapest
Hungary	Nyiro Gyula Korhaz, I. Pszichiatria	Budapest
Hungary	Nyiro Gyula Korhaz, II. Pszichiatria	Budapest
Japan	Yuge Hospital	Kumamoto
Japan	Asakayama General Hospital	Sakai	Osaka
Japan	Goryokai Medical Corporation	Sapporo-shi	Hokkaido
Japan	Nishigahara Hospital	Tokyo
Japan	Kawada Hospital	Toyama
Poland	NZOZ Syntonia	Gdynia
Poland	NZOZ BioMed	Kielce
Poland	NZOZ Prywatna Klinika Psychiatryczna Inventiva	Tuszyn
Russian Federation	State Healthcare and Forensic Psychiatric Expertise Institution	Izhevsk
Russian Federation	Nizhny Novgorod Regional State Institution of Healthcare	Novgorod
Russian Federation	St Petersburg State Government Healthcare Institution	St Petersburg
Russian Federation	Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"	St. Petersburg
Russian Federation	St. Petersburg State Healthcare Institution "City Clinical Hospital #4"	St. Petersburg
Russian Federation	Mental Health Research Institute of Siberian Branch of RAMS	Tomsk
Serbia	Clinical Hospital Centre Dragisa Misovic	Belgrade
Serbia	Clinical Centre Kragujevac, Psychiatric Hospital	Kragujevac
Serbia	Clinic for Mental Health Protection, Clinical Centre Nis	Nis
Serbia	Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"	Novi Knezevac
Slovakia	Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.	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	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 Clincial Research Center	Garlield Heights	Ohio
United States	Behavioral Research Specialists, LLC	Glendale	California
United States	Activ Med Practices & Research	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	Excell Research, Inc	Oceanside	California
United States	Cutting Edge Research Group	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,  Bulgaria,  Chile,  Czech Republic,  France,  Hungary,  Japan,  Poland,  Russian Federation,  Serbia,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation and serious adverse events	Treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation and serious adverse events	12 weeks	Yes
Secondary	Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations.	Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations.	12 weeks	Yes
Secondary	Weight - Body Mass Index (BMI) will be calculated in kg/m2.	Weight - Body Mass Index (BMI) will be calculated in kg/m2.	12 weeks	Yes
Secondary	Columbia Suicide Severity Rating Scale C-SSRS	Columbia Suicide Severity Rating Scale C-SSRS	12 weeks	Yes
Secondary	Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS)	Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS)	12 weeks	Yes
Secondary	Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score	Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score	12 weeks	No
Secondary	Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score	Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score	12 weeks	No
Secondary	Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score	Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score	12 weeks	No
Secondary	Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales	Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales	12 weeks	No
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)	Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)	12 weeks	No
Secondary	Pittsburgh Insomnia Rating Scale (PIRS-2)	Pittsburgh Insomnia Rating Scale (PIRS-2)	12 weeks	No
Secondary	Health Services Utilization Questionnaire (HSUQ) (US sites only)	Health Services Utilization Questionnaire (HSUQ) (US sites only)	12 weeks	No
Secondary	SF-12 Health Survey	SF-12 Health Survey	12 weeks	No
Secondary	Medication Satisfaction Questionnaire (MSQ)	Medication Satisfaction Questionnaire (MSQ)	12 weeks	No
Secondary	Intend to attend assessment	Intend to attend assessment	12 weeks	No
Secondary	Laboratory measures	Blood Chemistry Tests, Endocrine Tests, Hematology Tests, Urinalysis Tests, Urine Drug Screen	12 weeks	Yes
Secondary	Vital Signs	Orthostatic changes in blood pressure and heart rate, blood pressure, pulse, respiratory rate, and temperature	12 weeks	Yes
Secondary	Electrocardiogram	12-lead ECG	12 weeks	Yes
Secondary	Movement disorders assessed by Barnes Akathisia Rating Scale (BARS)	Movement disorders assessed by Barnes Akathisia Rating Scale (BARS)	12 weeks	Yes
Secondary	Movement disorders as assessed by Simpson-Angus Scale (SAS)	Movement disorders as assessed by Simpson-Angus Scale (SAS)	12 weeks	Yes
Secondary	Mania as assessed by Young Mania Rating Scale (YMRS)	Movement disorders as assessed by Young Mania Rating Scale (YMRS)	12 weeks	No
Secondary	Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS)	Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS)	12 weeks	No
Secondary	Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)	Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)	12 weeks	No
Secondary	Functionality as assessed by Sheehan Disability Scale (SDS)	Functionality as assessed by Sheehan Disability Scale (SDS)	12 weeks	No