Clinical trial NCT01284517: Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression
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 in Subjects Demonstrating Non-response to Treatment With Lithium or Divalproex Alone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Depression
Keywords: Bipolar I Depression
Lurasidone
Latuda
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 356
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: Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.


Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent and is 18 to 75 years of age inclusive.
2. Meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features.
3. Has a lifetime history of at least one bipolar manic or mixed manic episode.
4. Currently being treated with lithium or divalproex or willing to begin treatment with lithium or divalproex.
5. Not pregnant or nursing and is not planning pregnancy within the projected duration of the study.
6. Females of reproductive potential agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after
7. Good physical health on the basis of medical history, physical examination, and laboratory screening.

Exclusion Criteria:

1. Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
2. Any chronic organic disease of the CNS (other than Bipolar I Disorder).
3. Hospitalization for a manic or mixed episode within the past two months.
4. Used investigational compound within past 6 months.
5. Clinically significant history of alcohol or substance abuse within the past 3 months or alcohol or substance dependence within the past 12 months.

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: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Riverside
country: United States
facility: Clinical Innovations Inc.
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Santa Ana
country: United States
facility: Clinical Innovations inc.
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Highlands Ranch
country: United States
facility: Colorado Clinical Trials Inc.
state: Colorado
city: Kissimmee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Florida
city: Roswell
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Smyrna
country: United States
facility: Institute for Behavioral Medicine LLC
state: Georgia
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: New York
country: United States
facility: Village Clinical Research Inc.
state: New York
city: New York
country: United States
facility: Medical & Behavioral Health Research
state: New York
city: Raleigh
country: United States
facility: Zarzar Psychiatric Associates, PLLC
state: North Carolina
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Dallas
country: United States
facility: FutureSearch Clinical Trials, LP
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: Seattle
country: United States
facility: Summit Research Network (Seattle) LLC
state: Washington
city: Edmonton
country: Canada
facility: Clinical Research Group Edmonton Inc
state: Alberta
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: Gatineau
country: Canada
facility: Pierre-Janet Hospital
state: Quebec
city: Montreal
country: Canada
facility: Hopital Louis-H Lafontaine
state: Quebec
city: Barranquilla
country: Colombia
facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA
city: Bogota
country: Colombia
facility: Centro de Investigacion y Atencion para la Salud Mental
city: Bogota
country: Colombia
facility: CISNE - UIC Campo Abierto
city: Cali
country: Colombia
facility: Hospital Mental de Antioquia
city: Brno-mesto
country: Czech Republic
facility: Psychiatricka ambulance
city: Olomouc
country: Czech Republic
facility: Vojenska nemocnice Olomouc
city: Praha
country: Czech Republic
facility: Clintrial, s.r.o.
city: Praha
country: Czech Republic
facility: Psychiatry Trial s.r.o.
city: Vishakhapatnam
country: India
facility: Brain Mind Behavior Neuroscience Research Institute
state: Andh Prad
city: Kanchanpalli
country: India
facility: Shanti Nursing Home
state: Aurangabad, Maharashtra
city: Vadodara
country: India
facility: SBKS Medical College and Hospital, Brij Psychiatry Hospital
state: Gujarat
city: Bangalore
country: India
facility: Abhaya Hospital Psychiatry
state: Karna
city: Mangalore
country: India
facility: K.S. Hegde Medical Academy
state: Karna
city: Pune
country: India
facility: Poona Hospital & Research Center
state: Mahara
city: Wardha
country: India
facility: Mahatma Ghandi Institute of Medical Sciences
state: Mahara
city: Jaipur
country: India
facility: Mental Health Care & Research
state: Rajasthan
city: Jaipur
country: India
facility: R.K. Yadav Memorial Mental Health & De-addiction Hospital
state: Rajasthan
city: Kanpur
country: India
facility: Mahendru Psychiatric Center
state: Uttar Prad
city: Lucknow
country: India
facility: Chatrapati Shau Maharaj Medical University
state: Utter Prad
city: Hachioji-shi
country: Japan
facility: Ongata Hospital
city: Ichikawa
country: Japan
facility: Kohnodai Hospital, National Center for Global Health & Medicine
city: Kanzaki-gun
country: Japan
facility: National Hospital Organization Hizen Psychiatric Center
city: Kodaira-shi
country: Japan
facility: National Center of Neurology & Psychiatry
city: Sakai-shi
country: Japan
facility: Asakayama General Hospital
city: Takatsuki
country: Japan
facility: Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
city: Kaunas
country: Lithuania
facility: Neuromeda JSC
city: Kaunas
country: Lithuania
facility: Ziegzdriai Mental Hospital, Public Institution
city: Silute
country: Lithuania
facility: Silutes Mental Health & Psychtherapy Center, JSC
city: Vilnius
country: Lithuania
facility: Seskines Outpatient Clinic, Public Institution
city: Vilnius
country: Lithuania
facility: Zirmunai Mental Health Center, Public Institution
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza
city: Lima
country: Peru
facility: Hospital Nacional Hipolito Unanue
city: Lima
country: Peru
facility: Clinica Vesalio
city: Bardejov
country: Slovakia
facility: Centrum zdravia R. B. K. s.r.o.
city: Bojnice
country: Slovakia
facility: Bojniciach
city: Bratislava
country: Slovakia
facility: Psychiatricka ambulancia Mentum s.r.o.
city: Bratislava
country: Slovakia
facility: FNsP Bratislava, Nemocnica Ruzinov
city: Liptovsky Mikulas
country: Slovakia
facility: Nemocnica s poliklinikou Liptovsky Milulas
city: Rimavska Sobota
country: Slovakia
facility: PsychoLine s.r.o.
city: Roznava
country: Slovakia
facility: Nemocnica s poliklikou Sv. Barbory
city: Trencin
country: Slovakia
facility: Pro mente sana
city: Kherson
country: Ukraine
facility: Kherson Regional Psychiatric Hospital
state: Vil Stepanivka
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov
city: Dnipropetrovsk
country: Ukraine
facility: Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
city: Kharkov
country: Ukraine
facility: St. In. Inst of Neurol, Psych, and Narcol of the AMSU
city: Kyiv
country: Ukraine
facility: Kyiv City Psychoneurological Hospital #2
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Psychiatric Hospital
city: Ternopil
country: Ukraine
facility: Ternopil Regional Municipal Dispensary, Narcology Dept.
city: Zaporizhzhya
country: Ukraine
facility: Zapor. Reg. CI Hospital, Zaporizhzhia SMU
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Suppes T, Kroger H, Pikalov A, Loebel A. Lurasidone adjunctive with lithium or valproate for bipolar depression: A placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res. 2016 Jul;78:86-93. doi: 10.1016/j.jpsychires.2016.03.012. Epub 2016 Mar 31.