Clinical trial NCT00868699: Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Official title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: Bipolar I, Depression
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression


Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with bipolar I disorder, most resent episode depressed
* Subject must have a lifetime history of at least one bipolar manic or mixed episode

Exclusion Criteria:

* History of nonresponse to an adequate (6-week) trial of three or more antidepressants (with or without mood stabilizers) during the current episode
* Subject has been hospitalized for a manic or mixed episode within 60 days prior to randomization
* Imminent risk of suicide or injury to self, others, or property

Primary outcomes:
measure: Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
timeFrame: Baseline to Week 6
measure: Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Escondido
country: United States
facility: Synergy Escondido,710 East Grand Ave.
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc,3998 Vista Way,Suite 100
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Pico Rivera
country: United States
facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC,3914 State Road 64 East
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230
state: Florida
city: Tampa
country: United States
facility: Depression and Anxiety Disorders Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103
state: Florida
city: Oak Brook
country: United States
facility: American Medical Research Inc.,1200 Harger Road Suite 415
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System,6501 North Charles Street
state: Maryland
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209
state: New Mexico
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Raleigh
country: United States
facility: Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125
state: North Carolina
city: Cleveland
country: United States
facility: Mood Disorders Program-UHCMC
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Austin
country: United States
facility: FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200
state: Texas
city: Kolejni 429-5
country: Czech Republic
facility: Medical Services Prague s.r.o.
state: Praha
city: Brno - mesto
country: Czech Republic
facility: Psychiatricka ambulance
city: Litomerice
country: Czech Republic
facility: BIALBI s.r.o., Psychiatricke Oddeleni
city: Praha
country: Czech Republic
facility: Clintrial, s.r.o.
city: Nimes Cedex
country: France
facility: Hopital Caremeau, Service de Psychiatrie A
city: Orvault
country: France
facility: Zans Ritter, Marcel
city: Tirupati
country: India
facility: S V Medical College
state: Andh Prad
city: Vijaywada
country: India
facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry
state: Andh Prad
city: Ahmedabad
country: India
facility: Samvedna Hospitals
state: Gujarat
city: Ahmedabad
country: India
facility: Seth K M School of P G Medicine & Research
state: Gujarat
city: Ahmedabad
country: India
facility: Mental Illness Treatment Rehabilitationi Foundation
state: Gujarat
city: Bangalore
country: India
facility: Spandana Nursing Home
state: Karna
city: Nashik
country: India
facility: Sujata Birla Hospital & Research Centre
state: Mahara
city: Jaipur
country: India
facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital
state: Rajasthan
city: Lucknow
country: India
facility: Manobal Med. Research Centre
state: Uttar Prad
city: Bucdresti
country: Romania
facility: Spitalul Clinic de Urgenta Militar Central
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihaiatrie Prof. Dr. Alexandru Obregia
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj
city: Craiova
country: Romania
facility: Spitalul Clinic de Neuropsihiatrie Craiova
city: Oradea
country: Romania
facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets
city: St. Petersburg
country: Russian Federation
facility: Bekhterev Scientific Research Psychoneurological Institute
city: St. Petersburg
country: Russian Federation
facility: Psychoneurology Dispensary #4
city: Cape Town, W. Cape
country: South Africa
facility: Cape Trial Centre
city: Paarl, W. Cape
country: South Africa
facility: Paarl Medical Centre
city: Port Elizabeth, E. Cape
country: South Africa
facility: Clinika
city: Pretoria, Gauteng
country: South Africa
facility: Dey Clinic
city: Vereeniging, Free State
country: South Africa
facility: Vereeniging Medi-Clinic
city: Donetsk
country: Ukraine
facility: Chair of Psychiatry and Medical Psychology
city: Odessa
country: Ukraine
facility: Reg. Psychiatric Hospital
city: Poltava
country: Ukraine
facility: Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B
city: Simferopol
country: Ukraine
facility: CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I
city: Vinnitsia
country: Ukraine
facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.
citation: Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.
citation: Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.
citation: Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.
citation: Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.
citation: Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.
citation: McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.