Clinical trial NCT01358357: Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Keywords: Lurasidone
Latuda
Bipolar I
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 965
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Recurrence of Mood Event During the Double Blind Treatment Phase
timeFrame: 28 weeks (up to 33 weeks)
Secondary outcomes:
measure: Time to All-cause Discontinuation
timeFrame: 28 weeks (up to 33 weeks)
measure: Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
timeFrame: 28 weeks (up to 33 weeks)
measure: Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode
timeFrame: 28 weeks
measure: Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score
timeFrame: Double-blind Baseline to week 28
measure: Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score
timeFrame: Double-blind Baseline to week 28
measure: Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score
timeFrame: Double-blind Baseline to week 28
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research
state: Alabama
city: Glendale
country: United States
facility: Behavioral Research Specialists, LLC
state: California
city: Los Angeles
country: United States
facility: AXIS Clinical Trials
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: Palo Alto
country: United States
facility: Stanford University School of Medicine Research Program VA Palo Alto Health Care System
state: California
city: San Francisco
country: United States
facility: SF-CARE, Inc.
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Stanford
country: United States
facility: "Stanford University School of Medicine
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research LLC
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Haverhill
country: United States
facility: ActivMed Practices & Research Inc.
state: Massachusetts
city: St. Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: New York
country: United States
facility: Village Clinical Research Inc,
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Garfield Heights
country: United States
facility: Charak Center for Health and Wellness
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research Groupd
state: Oklahoma
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Dallas
country: United States
facility: Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Cordoba
country: Argentina
facility: Sanatorio Morra
state: Provincia de Cordoba
city: Rosario
country: Argentina
facility: Centro de Atencion E Invest. Clinica (CAICI)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novain Neurociencias Group
city: Buenos Aires
country: Argentina
facility: Centro de Neuropsiquiatria
city: Buenos Aires
country: Argentina
facility: IPEM-Instituto de Prevención de las Enfermedades Mentales.
city: Cordoba
country: Argentina
facility: Instituto DAMCI
city: La Plata
country: Argentina
facility: Clinica Privada de Salud Mental Santa Teresa de Avila
city: Mendoza
country: Argentina
facility: Centro de Psiquiatria Biologica
city: Elizabeth Vale
country: Australia
facility: The Lyell McEwin Hospital
state: South Australia
city: Malvern
country: Australia
facility: RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria
state: Victoria
city: Richmond
country: Australia
facility: The Melbourne Clinic
state: Victoria
city: Fremantle
country: Australia
facility: Hollywood Medical Centre
state: Western Australia
city: Bourgas
country: Bulgaria
facility: Psychiatry Dispensary
city: Plovdiv
country: Bulgaria
facility: University Multiprofiled Hospital for Active Treatment "Sveti Georgi"
city: Rousse
country: Bulgaria
facility: Regional Psychiatric Dispensary
city: Sofia
country: Bulgaria
facility: Multiprofiled Hospital for Active Treatment "Alexandrovska"
city: Sofia
country: Bulgaria
facility: Psychiatric Clinic, Military Medical Academy
city: Varna
country: Bulgaria
facility: Multprofiled Hospital for Active Treatment "Sveta Marina"
city: Santiago
country: Chile
facility: CETEP
city: Santiago
country: Chile
facility: Clinica Las Condes
city: Santiago
country: Chile
facility: Psicomedica
city: Rijeka
country: Croatia
facility: Clinic Hospital Centre Rijeka Clinic for Psychiatry
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Zagreb
country: Croatia
facility: Klinicki Bolnicki Centar Zagreb-Rebro
city: Zagreb
country: Croatia
facility: University Hospital Sestremilosrdnice
city: Zagreg
country: Croatia
facility: University Hospital Centre Zagreb
city: Brno-Bohunice
country: Czech Republic
facility: Fakultni Nemocnice Brno
city: Brno
country: Czech Republic
facility: Saint Anne s.r.o.
city: Havirov
country: Czech Republic
facility: Psychiatricka ambulance
city: Pisek
country: Czech Republic
facility: Psychiatricka Iecebna U Honzicka
city: Prague 8-Bohunice
country: Czech Republic
facility: Psychiatricke Centrum Praha
city: Prague
country: Czech Republic
facility: Psychiatricka Ambulance
city: Praha 10
country: Czech Republic
facility: Clintrial s.r.o.
city: Praha 3
country: Czech Republic
facility: Psychiatricka ambulance Prosek
city: Praha 4
country: Czech Republic
facility: Psychiaricka ambulance
city: Prerov
country: Czech Republic
facility: Psychosocialni Centrum
city: Usti nad labem
country: Czech Republic
facility: Psychiatricka ambulance
city: Dijon cedex
country: France
facility: CHS La Chartreuse-Pole 6
city: Dole
country: France
facility: Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique
city: Montpellier Cedex 5
country: France
facility: Hopital Lapeyronie
city: Nimes Cedex 09
country: France
facility: CHRU de Nimes, Service de Psychiatrie adulte
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centurm Kft.
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz
city: Budapest
country: Hungary
facility: Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz
city: Shibukawa
country: Japan
facility: Haruna Hospital
state: Gunma
city: Sapporo-shi
country: Japan
facility: Goryokai Medical Corporation
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporokousetsu Hospital
state: Hokkaido
city: Komagane,
country: Japan
facility: Nagano Prefectural Mental Wellness Center-Komagane
state: Nagano
city: Matsumoto-shi
country: Japan
facility: Shonan Hospital
state: Nagano
city: Sakai
country: Japan
facility: Asakayama General Hospital
state: Osaka
city: Kanzaki
country: Japan
facility: National Hospital Organization Hizen Psychiatric Center
state: Saga
city: Kita-ku
country: Japan
facility: Nishigahara Hospital
state: Tokyo
city: Aichi
country: Japan
facility: Okehazama Hospital Fujita Kokoro Care Center
city: Hachioji, Tokyo
country: Japan
facility: Ongata Hospital
city: Kumamoto
country: Japan
facility: Yuge Hospital
city: Okinawa
country: Japan
facility: Arakaki Hospital
city: Toyama
country: Japan
facility: Kawada Hospital
city: Gdynia
country: Poland
facility: NZOZ Syntonia
city: Kielce
country: Poland
facility: NZOZ BioMed
city: Torun
country: Poland
facility: Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu
city: Tuszyn
country: Poland
facility: Prywatny Gabinet Lekarski Jaroslaw Strzelec
city: Wroclaw
country: Poland
facility: Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy
city: Izhevsk
country: Russian Federation
facility: State Healthcare and Forensic Psychiatric Expertise Institution
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional State Institution of Healthcare
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution (SPSHI)
city: St. Petersburg
country: Russian Federation
facility: St.Petersburg State Healthcare Institution (SPSHI)
city: St. Petersburg
country: Russian Federation
facility: St Petersburg State Government Healthcare Institution
city: Tomsk
country: Russian Federation
facility: Mental Health Research Institute of Rams
city: Belgrade
country: Serbia
facility: Clinical Centre of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Dragisa Misovic
city: Kragujevac
country: Serbia
facility: Psychiatric Clinic Clinical Center Kragujevac
city: Nis
country: Serbia
facility: Clinical Centre Nis
city: Novi Knezevac
country: Serbia
facility: Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
city: Rimavska Sobota
country: Slovakia
facility: Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava
city: Zlate Moravce
country: Slovakia
facility: Psychiatricka ambulancia
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References: