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

NCT01575561 | Completed Phase 3 Results

• 2 other identifiers: D10503082011-004789-14
• Study Type: interventional
• Target: 377
• Locations: 12 countries
• Sites: 71

Brief 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

Conditions

Bipolar I Disorder

Keywords

Lurasidone; Latuda; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events

  Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation

  12 weeks

Secondary Outcomes (8)

• Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score

  baseline, 12 weeks (LOCF)

• Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score

  baseline, 12 weeks (LOCF)

• Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)

  Baseline, 12 weeks (LOCF)

• Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

  baseline ,Week 12 (LOCF)

• Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)

  baseline, week 12 (LOCF)

Study Arms (1)

Lurasidone

EXPERIMENTAL

Lurasidone 20, 40, 60,80 mg flexible dose

Drug: Lurasidone

Interventions

Lurasidone DRUG

Lurasidone 20-80 mg taken orally once daily

Lurasidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• 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).

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (71)

Harmonex Neuroscience Research

Dothan, Alabama, 36303, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

AXIS Clinical Trials

Los Angeles, California, 90036, United States

Location

Excell Research, Inc

Oceanside, California, 92056, United States

Location

Stanford University School of Medicine Research Program VA Palo Alto Health Care System

Palo Alto, California, 93404, United States

Location

SF-Care, Inc.

San Francisco, California, 94117, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Stanford University School of Medicine

Stanford, California, 93405, United States

Location

Florida Clinical Research LLC

Bradenton, Florida, 34201, United States

Location

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, 32216, United States

Location

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32806, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Clinco

Terre Haute, Indiana, 47802, United States

Location

Activ Med Practices & Research

Haverhill, Massachusetts, 08130, United States

Location

Psych Care Consultants Research

St Louis, Missouri, 63128, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Charak Clincial Research Center

Garlield Heights, Ohio, 44125, United States

Location

Cutting Edge Research Group

Oklahoma City, Oklahoma, 73116, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Lincoln Research

Lincoln, Rhode Island, 02865, United States

Location

Carolina Clinical Trials

Charleston, South Carolina, 29407, United States

Location

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38119, United States

Location

Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Clinica Privada de Salud Mental Santa Teresa de Avila

Buenos Aires, 1900, Argentina

Location

Novain Neurociencias Group

Buenos Aires, C1117ABH, Argentina

Location

Instituto Nacional de Psicopatología (INAPSI)

Buenos Aires, C1405BOA, Argentina

Location

Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)

Buenos Aires, C1425AHQ, Argentina

Location

Instituto DAMIC SRL

Córdoba, 5003, Argentina

Location

Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

Rosario, 2000, Argentina

Location

Center for Mental Health

Rousse, 7003, Bulgaria

Location

Multiprofiled Hospital for Active Treatment "Alexandrovska"

Sofia, 1431, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Hospital El Pino

Santiago, 8053095, Chile

Location

Clinica Pedro Montt

Santiago, 8330838, Chile

Location

Saint Anne, s.r.o., Psychiatricke oddeleni

Brno - Mesto, 602 00, Czechia

Location

Psychiatricka ambulance

Havířov, 73601, Czechia

Location

Psychiatricka lecebna U Honzicka

Písek, 397 01, Czechia

Location

Clintrial s.r.o.

Prague, 100 00, Czechia

Location

Psychiatricka ambulance

Prague, 106 00, Czechia

Location

Psychiatricka ambulance

Prague, 149 00, Czechia

Location

Psychiatricka ambulance Prosek

Prague, 190 00, Czechia

Location

Telemens, s.r.o.

Přerov, 750 01, Czechia

Location

CHS La Chartreuse - Pôle 6

Dijon, 21033, France

Location

Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique

Dole, 39100, France

Location

Centre Hospitalier Régional Universitaire

Nîmes, 30900, France

Location

Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

Budapest, 1125, Hungary

Location

Nyiro Gyula Korhaz, I. Pszichiatria

Budapest, 1135, Hungary

Location

Nyiro Gyula Korhaz, II. Pszichiatria

Budapest, 1135, Hungary

Location

Nyiro Gyula Korhaz

Budapest, 1135, Hungary

Location

Goryokai Medical Corporation

Sapporo, Hokkaido, 002-8029, Japan

Location

Asakayama General Hospital

Sakai, Osaka, Japan

Location

Yuge Hospital

Kumamoto, 861-8002, Japan

Location

Nishigahara Hospital

Tokyo, 114-0024, Japan

Location

Kawada Hospital

Toyama, 933-0917, Japan

Location

NZOZ Syntonia

Gdynia, 81-361, Poland

Location

NZOZ BioMed

Kielce, 25-411, Poland

Location

NZOZ Prywatna Klinika Psychiatryczna Inventiva

Tuszyn, 95-080, Poland

Location

State Healthcare and Forensic Psychiatric Expertise Institution

Izhevsk, 426054, Russia

Location

Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"

Saint Petersburg, 190005, Russia

Location

St Petersburg State Government Healthcare Institution

Saint Petersburg, 190121, Russia

Location

St. Petersburg State Healthcare Institution "City Clinical Hospital #4"

Saint Petersburg, 191119, Russia

Location

Mental Health Research Institute of Siberian Branch of RAMS

Tomsk, 634014, Russia

Location

Nizhny Novgorod Regional State Institution of Healthcare

Veliky Novgorod, 603155, Russia

Location

Clinical Hospital Centre Dragisa Misovic

Belgrade, 11000, Serbia

Location

Clinical Centre Kragujevac, Psychiatric Hospital

Kragujevac, 34000, Serbia

Location

Clinic for Mental Health Protection, Clinical Centre Nis

Niš, 18000, Serbia

Location

Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

Novi Kneževac, 23330, Serbia

Location

Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.

Rimavská Sobota, 97912, Slovakia

Location

Psychiatricka ambulancia

Zlaté Moravce, 95301, Slovakia

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lurasidone Hydrochloride

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• Lurasidone Medical Director, MD

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 11, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 22, 2016
• Results First Posted: August 22, 2016

Record last verified: 2016-07

Locations

HU (4); PL (3); JP (5); BU (3); CL (2); SE (4); CZ (8); FR (3); RU (6); SL (2); US (25); AR (6)