Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression (PREVAIL3)

October 31, 2013 updated by: Sunovion

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6L 6W6
        • Clinical Research Group Edmonton Inc
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials
    • Quebec
      • Gatineau, Quebec, Canada, J9A 1K7
        • Pierre-Janet Hospital
      • Montreal, Quebec, Canada, H1N 3M5
        • Hopital Louis-H Lafontaine
  • Colombia
      • Barranquilla, Colombia
        • Centro de Investigaciones y Proyectos en Neurociencias CIPNA
      • Bogota, Colombia, 103
        • Centro de Investigación y Atención para la Salud Mental
      • Bogota, Colombia
        • CISNE - UIC Campo Abierto
      • Cali, Colombia
        • Hospital Mental de Antioquia
  • Czech Republic
      • Brno-mesto, Czech Republic, 602 00
        • Psychiatricka ambulance
      • Olomouc, Czech Republic, 711 11
        • Vojenska nemocnice Olomouc
      • Praha, Czech Republic, 10 100 00
        • CLINTRIAL, s.r.o.
      • Praha, Czech Republic, 158 00
        • Psychiatry Trial s.r.o.
  • India
    • Andh Prad
      • Vishakhapatnam, Andh Prad, India, 530002
        • Brain Mind Behavior Neuroscience Research Institute
    • Aurangabad, Maharashtra
      • Kanchanpalli, Aurangabad, Maharashtra, India
        • Shanti Nursing Home
    • Gujarat
      • Vadodara, Gujarat, India, 390001
        • SBKS Medical College and Hospital, Brij Psychiatry Hospital
    • Karna
      • Bangalore, Karna, India, 560027
        • Abhaya Hospital Psychiatry
      • Mangalore, Karna, India, 575018
        • K.S. Hegde Medical Academy
    • Mahara
      • Pune, Mahara, India, 411 030
        • Poona Hospital & Research Center
      • Wardha, Mahara, India, 442102
        • Mahatma Ghandi Institute of Medical Sciences
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Mental Health Care & Research
      • Jaipur, Rajasthan, India, 302021
        • R.K. Yadav Memorial Mental Health & De-Addiction Hospital
    • Uttar Prad
      • Kanpur, Uttar Prad, India, 208005
        • Mahendru Psychiatric Center
    • Utter Prad
      • Lucknow, Utter Prad, India, 226003
        • Chatrapati Shau Maharaj Medical University
  • Japan
      • Hachioji-shi, Japan, 192 0153, 13
        • Ongata Hospital
      • Ichikawa, Japan, 272 8516 12
        • Kohnodai Hospital, National Center for Global Health & Medicine
      • Kanzaki-gun, Japan, 842 0192 41
        • National Hospital Organization Hizen Psychiatric Center
      • Kodaira-shi, Japan, 187 8551 13
        • National Center of Neurology & Psychiatry
      • Sakai-shi, Japan, 590 0018, 27
        • Asakayama General Hospital
      • Takatsuki, Japan, 569-1041
        • Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
  • Lithuania
      • Kaunas, Lithuania, 50185
        • Neuromeda JSC
      • Kaunas, Lithuania, 53136
        • Ziegzdriai Mental Hospital, Public Institution
      • Silute, Lithuania, 99142
        • Silutes Mental Health & Psychtherapy Center, JSC
      • Vilnius, Lithuania, 07156
        • Seskines Outpatient Clinic, Public Institution
      • Vilnius, Lithuania, 09112
        • Zirmunai Mental Health Center, Public Institution
  • Peru
      • Lima, Peru, 01
        • Hospital Nacional Arzobispo Loayza
      • Lima, Peru, 27
        • Hospital Nacional Hipólito Unanue
      • Lima, Peru, 41
        • Clinica Vesalio
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • Centrum zdravia R. B. K. s.r.o.
      • Bojnice, Slovakia, 97201
        • Bojniciach
      • Bratislava, Slovakia, 82007
        • Psychiatricka Ambulancia Mentum S.R.O.
      • Bratislava, Slovakia, 82606
        • FNsP Bratislava, Nemocnica Ruzinov
      • Liptovsky Mikulas, Slovakia, 03123
        • Nemocnica s poliklinikou Liptovsky Milulas
      • Rimavska Sobota, Slovakia, 97901
        • PsychoLine s.r.o.
      • Roznava, Slovakia, 048 01
        • Nemocnica s poliklikou Sv. Barbory
      • Trencin, Slovakia, 91101
        • Pro mente sana
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49005
        • Dnipropetrovsk Regional Clinical Hospital named Mechnikov
      • Dnipropetrovsk, Ukraine, 49115
        • Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA
      • Kharkov, Ukraine
        • St. In. Inst of Neurol, Psych, and Narcol of the AMSU
      • Kyiv, Ukraine, 02660
        • Kyiv City Psychoneurological Hospital #2
      • Lviv, Ukraine, 79021
        • Lviv Regional Clinical Psychiatric Hospital
      • Ternopil, Ukraine, 46020
        • Ternopil Regional Municipal Dispensary, Narcology Dept.
      • Zaporizhzhya, Ukraine, 69032
        • Zapor. Reg. CI Hospital, Zaporizhzhia SMU
    • Vil Stepanivka
      • Kherson, Vil Stepanivka, Ukraine, 73488
        • Kherson Regional Psychiatric Hospital
  • United States
    • California
      • Costa Mesa, California, United States, 92647
        • Clinical Innovations, Inc.
      • Riverside, California, United States, 92506
        • Clinical Innovations Inc.
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
      • Santa Ana, California, United States, 92705
        • Clinical Innovations Inc.
      • Torrance, California, United States, 90502
        • Collaborative NeuroScience Network
    • Colorado
      • Highlands Ranch, Colorado, United States, 80130
        • Colorado Clinical Trials Inc.
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Accurate Clinical Trials
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions Inc.
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Northwest Behavioral Research Center
      • Smyrna, Georgia, United States, 30080
        • Institute for Behavioral Medicine LLC
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Precise Research Centers
    • New York
      • New York, New York, United States, 10003
        • Village Clinical Research Inc.
      • New York, New York, United States, 10023
        • Medical & Behavioral Health Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Zarzar Psychiatric Associates, Pllc
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Dallas, Texas, United States, 75231
        • FutureSearch Clinical Trials, LP
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
    • Washington
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle) Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Equivalent to Lurasidone dosing
Experimental: Lurasidone 20-120 mg flexible dose
Drug: Lurasidone
Tablets 20-120 mg, PM dosing,daily for 6 weeks
Other Names:
  • Latuda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6)
Time Frame: Baseline to 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Endpoint (Week 6) in: Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Time Frame: Baseline to week 6
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
Mean Change From Baseline to Endpoint (Week 6) in: Sheehan Disability Scale (SDS) Total Score
Time Frame: Baseline to week 6
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 25, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimate)

January 27, 2011

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1050292
  • 2010-019778-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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