Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

NCT01358357 | Completed Phase 3 Results DMC

• 2 other identifiers: D10502962011-000986-10
• Study Type: interventional
• Target: 965
• Locations: 14 countries
• Sites: 105

Brief 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.

Conditions

Bipolar I Disorder

Keywords

Lurasidone; Latuda; Bipolar I

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence of Mood Event During the Double Blind Treatment Phase

  A mood event is defined as one of the following during the double-blind phase: (1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator).

  28 weeks (up to 33 weeks)

Secondary Outcomes (13)

• Time to All-cause Discontinuation

  28 weeks (up to 33 weeks)

• Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode

  28 weeks (up to 33 weeks)

• Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode

  28 weeks

• Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score

  Double-blind Baseline to week 28

• Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score

  Double-blind Baseline to week 28

Study Arms (2)

Lurasidone 20-80 mg flexible dose

EXPERIMENTAL

Drug: Lurasidone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lurasidone DRUG

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

Lurasidone 20-80 mg flexible dose

Placebo DRUG

20-80 mg flexible dose

Placebo

Eligibility Criteria

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

You may qualify if:

• Open-label Phase
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (105)

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, 94304, 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, 94305, 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

ActivMed Practices & Research Inc.

Haverhill, Massachusetts, 08130, United States

Location

Psych Care Consultants Research

St Louis, Missouri, 63128, United States

Location

Village Clinical Research Inc,

New York, New York, 10003, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Charak Center for Health and Wellness

Garfield Heights, Ohio, 44125, United States

Location

Cutting Edge Research Groupd

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, Inc.

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

Sanatorio Morra

Córdoba, Córdoba Province, 5009, Argentina

Location

Centro de Atencion E Invest. Clinica (CAICI)

Rosario, Santa Fe Province, 2000, Argentina

Location

Novain Neurociencias Group

Buenos Aires, C1117ABH, Argentina

Location

Centro de Neuropsiquiatria

Buenos Aires, C1425AHQ, Argentina

Location

IPEM-Instituto de Prevención de las Enfermedades Mentales.

Buenos Aires, Argentina

Location

Instituto DAMCI

Córdoba, 5009, Argentina

Location

Clinica Privada de Salud Mental Santa Teresa de Avila

La Plata, 1900, Argentina

Location

Centro de Psiquiatria Biologica

Mendoza, 5500, Argentina

Location

The Lyell McEwin Hospital

Elizabeth Vale, South Australia, 5112, Australia

Location

RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria

Malvern, Victoria, 3144, Australia

Location

The Melbourne Clinic

Richmond, Victoria, 3121, Australia

Location

Hollywood Medical Centre

Fremantle, Western Australia, 6160, Australia

Location

Psychiatry Dispensary

Burgas, 80000, Bulgaria

Location

University Multiprofiled Hospital for Active Treatment "Sveti Georgi"

Plovdiv, 4002, Bulgaria

Location

Regional Psychiatric Dispensary

Rousse, 7003, Bulgaria

Location

Multiprofiled Hospital for Active Treatment "Alexandrovska"

Sofia, 1431, Bulgaria

Location

Psychiatric Clinic, Military Medical Academy

Sofia, 1606, Bulgaria

Location

Multprofiled Hospital for Active Treatment "Sveta Marina"

Varna, 9010, Bulgaria

Location

CETEP

Santiago, 27014, Chile

Location

Clinica Las Condes

Santiago, 27014, Chile

Location

Psicomedica

Santiago, 27014, Chile

Location

Clinic Hospital Centre Rijeka Clinic for Psychiatry

Rijeka, 51000, Croatia

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Klinicki Bolnicki Centar Zagreb-Rebro

Zagreb, 10000, Croatia

Location

University Hospital Sestremilosrdnice

Zagreb, Croatia

Location

University Hospital Centre Zagreb

Zagreg, 10000, Croatia

Location

Saint Anne s.r.o.

Brno, 602 00, Czechia

Location

Fakultni Nemocnice Brno

Brno-Bohunice, 62500, Czechia

Location

Psychiatricka ambulance

Havířov, 736 01, Czechia

Location

Psychiatricka Iecebna U Honzicka

Písek, 397 01, Czechia

Location

Clintrial s.r.o.

Prague, 100 00, Czechia

Location

Psychiatricka Ambulance

Prague, 10600, Czechia

Location

Psychiaricka ambulance

Prague, 140 00, Czechia

Location

Psychiatricka ambulance Prosek

Prague, 190 00, Czechia

Location

Psychiatricke Centrum Praha

Prague 8-Bohunice, 62500, Czechia

Location

Psychosocialni Centrum

Přerov, 75001, Czechia

Location

Psychiatricka ambulance

Ústí nad Labem, 401 13, Czechia

Location

CHS La Chartreuse-Pole 6

Dijon, 21033, France

Location

Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique

Dole, 39100, France

Location

Hopital Lapeyronie

Montpellier, 34295, France

Location

CHRU de Nimes, Service de Psychiatrie adulte

Nîmes, 30029, France

Location

Obudai Egeszsegugyi Centurm Kft.

Budapest, 1036, Hungary

Location

Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz

Budapest, 1096, Hungary

Location

Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

Budapest, 1125, Hungary

Location

Nyiro Gyula Korhaz

Budapest, 1135, Hungary

Location

Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria

Budapest, H-1135, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz

Gyula, 5700, Hungary

Location

Haruna Hospital

Shibukawa, Gunma, Japan

Location

Goryokai Medical Corporation

Sapporo, Hokkaido, 002-8029, Japan

Location

Sapporokousetsu Hospital

Sapporo, Hokkaido, Japan

Location

Nagano Prefectural Mental Wellness Center-Komagane

Komagane, Nagano, Japan

Location

Shonan Hospital

Matsumoto-shi, Nagano, 390-0847, Japan

Location

Asakayama General Hospital

Sakai, Osaka, Japan

Location

National Hospital Organization Hizen Psychiatric Center

Kanzaki, Saga-ken, 842-0192, Japan

Location

Nishigahara Hospital

Kita-ku, Tokyo, 114-0024, Japan

Location

Okehazama Hospital Fujita Kokoro Care Center

Aichi, 470-1168, Japan

Location

Ongata Hospital

Hachioji, Tokyo, Japan

Location

Yuge Hospital

Kumamoto, 861-8002, Japan

Location

Arakaki Hospital

Okinawa, 904-0012, Japan

Location

Kawada Hospital

Toyama, 933-0917, Japan

Location

NZOZ Syntonia

Gdynia, 81-361, Poland

Location

NZOZ BioMed

Kielce, 25411, Poland

Location

Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu

Torun, 87-100, Poland

Location

Prywatny Gabinet Lekarski Jaroslaw Strzelec

Tuszyn, 95-080, Poland

Location

Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy

Wroclaw, 50-227, Poland

Location

State Healthcare and Forensic Psychiatric Expertise Institution

Izhevsk, 462054, Russia

Location

Nizhny Novgorod Regional State Institution of Healthcare

Nizhny Novgorod, 603155, Russia

Location

St. Petersburg State Healthcare Institution (SPSHI)

Saint Petersburg, 190005, Russia

Location

St.Petersburg State Healthcare Institution (SPSHI)

Saint Petersburg, 190005, Russia

Location

St Petersburg State Government Healthcare Institution

Saint Petersburg, 190121, Russia

Location

Mental Health Research Institute of Rams

Tomsk, 634050, Russia

Location

Clinical Centre of Serbia

Belgrade, 11000, Serbia

Location

Clinical Hospital Centre Dragisa Misovic

Belgrade, 11000, Serbia

Location

Psychiatric Clinic Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Clinical Centre Nis

Niš, 18000, Serbia

Location

Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

Novi Kneževac, 23330, Serbia

Location

Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava

Rimavská Sobota, 97912, Slovakia

Location

Psychiatricka ambulancia

Zlaté Moravce, 95301, Slovakia

Location

MeSH Terms

Interventions

Lurasidone Hydrochloride

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 Pharmaceuticlas Inc.

clinicaltrialdisclosure@sunvion.com

1-866-503-6351

Study Officials

• 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: 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: May 19, 2011
• First Posted: May 23, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: September 7, 2016
• Results First Posted: July 26, 2016

Record last verified: 2016-07

Locations

CZ (11); SL (2); PL (5); CL (3); US (26); HU (7); AU (4); SE (5); RU (6); CR (5); AR (8); BU (6); FR (4); JP (13)