Clinical trial NCT00868452: Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
Official title: A Randomized, 6-Week, Double-Blind, Placebo- Controlled, Flexible-Dose, Parallel-Group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Treatment of Bipolar I Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: Bipolar I
Latuda
Lurasidone
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-03-25
Enrollment: 348
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 when added to treatment with lithium or Divalproex 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
* Subject must be taking lithium or divalproex at least 28 days prior to screening

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, 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 Week 6
measure: Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
timeFrame: Baselin Week 6
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International Research Inc.
state: Arkansas
city: Anaheim
country: United States
facility: South Coast Clinical Trials, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute
state: California
city: Escondido
country: United States
facility: Synergy Escondido
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Pico Rivera
country: United States
facility: CNRI - Los Angeles LLC,8309 Telegraph Road
state: California
city: San Diego
country: United States
facility: CNRI - San Diego, LLC
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Tampa
country: United States
facility: Depression and Anxiety Disorders Research Institue
state: Florida
city: Oak Brook
country: United States
facility: American Medical Research Inc.,1200 Harger Road Suite 415
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc., 1200 Harger Road Suite 415
state: Illinois
city: Shreveport
country: United States
facility: J. Gary Booker, MD
state: Louisiana
city: Baltimore
country: United States
facility: Sheppard Pratt Health System,6501 North Charles Street
state: Maryland
city: Rockville
country: United States
facility: Capital Clinical Research,5515 Security Lane, Suite 525
state: Maryland
city: St. Charles
country: United States
facility: Midwest Research Group
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience Inc.,101 Hospital Loop, Suite 209
state: New Mexico
city: Raleigh
country: United States
facility: Lake Charles Clinical Trials LLC,700 Spring Forest Road
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler , M.D., PA.,& Associates, 700 Spring Forest Road, Suite 125
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Mood Disorders Program-UHCMC
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth System
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical research Center, One Elizabeth Place, Suite G-3
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: 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: Praha
country: Czech Republic
facility: Medical Services Prague s.r.o.
city: Praha
country: Czech Republic
facility: Psychiatricka ambulance Prosek
city: Nimes Cedex
country: France
facility: Hopital Caremeau, Service de Psychiatrie A
city: Orvault
country: France
facility: Zans Ritter, Marcel
city: Berlin BE
country: Germany
facility: Jana Thomsen
city: Tirupati
country: India
facility: SV 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: Sheth Vadilal Sarabhai General Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Mental Illness Treatment Rehabilitation Foundation (MITR)
state: Gujarat
city: Junagadh
country: India
facility: Shree Hatkesh Health 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: Delhi
country: India
facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry
city: Chelmno
country: Poland
facility: ZOZ Poradnia Zdrowia Psychicznego
city: Skorzewo
country: Poland
facility: Praktyka Lekarska Sensorium S.M.O.
city: Warszawa
country: Poland
facility: Wojewodzki Szpital Brodnowski SP ZOZ
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Militar Central "Prof. Dr. Carol" Psihiatrie
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: Pitesti
country: Romania
facility: Spitalul Judetean de Urgenta Pitesti Sectia de Psihiatric
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: Moscow Medical Academy named I.M. Sechenov
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: St. Petersburg
country: Russian Federation
facility: LLC International Medical Centre "SOGAZ"
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: Reg. Clinic Psych. Hosp., Dept 11, DNMU n.a.M. Gorkiy
city: Odesa
country: Ukraine
facility: Odesa Regional Psychoneurological Dispensary
city: Poltava
country: Ukraine
facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM
city: Simferopol
country: Ukraine
facility: CRI"Cl. Psych.Hosp.#1, Fem Psych.Dept.#2, Male Psych.Dept.#1
city: Vinnitsia
country: Ukraine
facility: Reg. Psych. Hosp. n.a. O.Yuschenko, Dept. #21, VNMUn.a.M. Pirog
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Loebel A, Cucchiaro J, Silva R, Kroger H, Sarma K, Xu J, Calabrese JR. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):169-77. doi: 10.1176/appi.ajp.2013.13070985.
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.