Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression

Bipolar Depression Clinical Trial

— PREVAIL3  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284517
• Other study ID #: D1050292
• Secondary ID: 2010-019778-34
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2011
• Last updated: October 31, 2013
• Start date: November 2010
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaChina: Ministry of HealthColombia: National Institutes of HealthCzech Republic: State Institute for Drug ControlIndia: Drugs Controller General of IndiaJapan: Pharmaceuticals and Medical Devices AgencyPeru: Ministry of HealthSlovakia: State Institute for Drug ControlUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
• Placebo
Equivalent to Lurasidone dosing

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Canada,  Colombia,  Czech Republic,  India,  Japan,  Lithuania,  Peru,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)	MADRS total score ranges from a minimum of 0 to a maximum of 60. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.	Baseline to week 6	No
Secondary	Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)	CGI-EP-S depression score ranges from a minimum of 0 to a maximum of 7. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.	Baseline to week 6	No
Secondary	Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score	SDS total score ranges from a minimum of 0 to a maximum of 30. Lower values represent a better score, higher values represent a worse score. Similarly, greater negative change from baseline represents improvement, and positive changes from baseline represent worsening.	Baseline to week 6	No