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Bipolar DepressionPhase 3PREVAIL3NCT01284517

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

A Phase 3 study testing Lurasidone in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 75 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bipolar Depression
What is being tested?
Lurasidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
356 participants
Where
75 sitesin 10 countries
Study dates
Nov 2010to Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

75 sites in 10 countries.

75 sites in 10 countries

United States22 sites

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Clinical Innovations, Inc.

    Costa Mesa, California, 92647

  • FutureSearch Clinical Trials, LP

    Dallas, Texas, 75231

  • Pillar Clinical Research

    Dallas, Texas, 75243

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Colorado Clinical Trials Inc.

    Highlands Ranch, Colorado, 80130

  • Red Oak Psychiatry Associates, PA

    Houston, Texas, 77090

  • Accurate Clinical Trials

    Kissimmee, Florida, 34741

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • Village Clinical Research Inc.

    New York, New York, 10003

  • Medical & Behavioral Health Research

    New York, New York, 10023

  • Clinical Neuroscience Solutions Inc.

    Orlando, Florida, 32806

  • Summit Research Network (Oregon) Inc.

    Portland, Oregon, 97210

  • Zarzar Psychiatric Associates, PLLC

    Raleigh, North Carolina, 27607

  • Clinical Innovations Inc.

    Riverside, California, 92506

  • Northwest Behavioral Research Center

    Roswell, Georgia, 30076

  • Artemis Institute for Clinical Research

    San Diego, California, 92123

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • Clinical Innovations inc.

    Santa Ana, California, 92705

  • Summit Research Network (Seattle) LLC

    Seattle, Washington, 98104

  • Institute for Behavioral Medicine LLC

    Smyrna, Georgia, 30080

  • Collaborative Neuroscience Network

    Torrance, California, 90502

Other trials in United States

India11 sites

  • Abhaya Hospital Psychiatry

    Bangalore, Karna, 560027

  • Mental Health Care & Research

    Jaipur, Rajasthan, 302017

  • R.K. Yadav Memorial Mental Health & De-addiction Hospital

    Jaipur, Rajasthan, 302021

  • Shanti Nursing Home

    Kanchanpalli, Aurangabad, Maharashtra

  • Mahendru Psychiatric Center

    Kanpur, Uttar Prad, 208005

  • Chatrapati Shau Maharaj Medical University

    Lucknow, Utter Prad, 226003

  • K.S. Hegde Medical Academy

    Mangalore, Karna, 575018

  • Poona Hospital & Research Center

    Pune, Mahara, 411 030

  • SBKS Medical College and Hospital, Brij Psychiatry Hospital

    Vadodara, Gujarat, 390001

  • Brain Mind Behavior Neuroscience Research Institute

    Visakhapatnam, Andh Prad, 530002

  • Mahatma Ghandi Institute of Medical Sciences

    Wardha, Mahara, 442102

Other trials in India

Slovakia8 sites

  • Centrum zdravia R. B. K. s.r.o.

    Bardejov, 085 01

  • Bojniciach

    Bojnice, 97201

  • Psychiatricka ambulancia Mentum s.r.o.

    Bratislava, 82007

  • FNsP Bratislava, Nemocnica Ruzinov

    Bratislava, 82606

  • Nemocnica s poliklinikou Liptovsky Milulas

    Liptovský Mikuláš, 03123

  • PsychoLine s.r.o.

    Rimavská Sobota, 97901

  • Nemocnica s poliklikou Sv. Barbory

    Rožňava, 048 01

  • Pro mente sana

    Trenčín, 91101

Other trials in Slovakia

Ukraine8 sites

  • Dnipropetrovsk Regional Clinical Hospital named Mechnikov

    Dnipropetrovsk, 49005

  • Com Inst Knipropetrovsk Reg Cl Psych Hospital DSMA

    Dnipropetrovsk, 49115

  • St. In. Inst of Neurol, Psych, and Narcol of the AMSU

    Kharkiv

  • Kherson Regional Psychiatric Hospital

    Kherson, Vil Stepanivka, 73488

  • Kyiv City Psychoneurological Hospital #2

    Kyiv, 02660

  • Lviv Regional Clinical Psychiatric Hospital

    Lviv, 79021

  • Ternopil Regional Municipal Dispensary, Narcology Dept.

    Ternopil, 46020

  • Zapor. Reg. CI Hospital, Zaporizhzhia SMU

    Zaporizhzhya, 69032

Other trials in Ukraine

Japan6 sites

  • Ongata Hospital

    Hachioji-shi, 192 0153, 13

  • Kohnodai Hospital, National Center for Global Health & Medicine

    Ichikawa, 272 8516 12

  • National Hospital Organization Hizen Psychiatric Center

    Kanzaki-gun, 842 0192 41

  • National Center of Neurology & Psychiatry

    Kodaira-shi, 187 8551 13

  • Asakayama General Hospital

    Sakaishi, 590 0018, 27

  • Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

    Takatsuki, 569-1041

Other trials in Japan

Lithuania5 sites

  • Neuromeda JSC

    Kaunas, 50185

  • Ziegzdriai Mental Hospital, Public Institution

    Kaunas, 53136

  • Silutes Mental Health & Psychtherapy Center, JSC

    Šilutė, 99142

  • Seskines Outpatient Clinic, Public Institution

    Vilnius, 07156

  • Zirmunai Mental Health Center, Public Institution

    Vilnius, 09112

Other trials in Lithuania

Canada4 sites

  • Clinical Research Group Edmonton Inc

    Edmonton, Alberta, T6L 6W6

  • Pierre-Janet Hospital

    Gatineau, Quebec, J9A 1K7

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • Hopital Louis-H Lafontaine

    Montreal, Quebec, H1N 3M5

Other trials in Canada

Colombia4 sites

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    Barranquilla

  • Centro de Investigacion y Atencion para la Salud Mental

    Bogotá, 103

  • CISNE - UIC Campo Abierto

    Bogotá

  • Hospital Mental de Antioquia

    Cali

Other trials in Colombia

Czechia4 sites

  • Psychiatricka ambulance

    Brno-mesto, 602 00

  • Vojenska nemocnice Olomouc

    Olomouc, 711 11

  • Clintrial, s.r.o.

    Prague, 10 100 00

  • Psychiatry Trial s.r.o.

    Prague, 158 00

Other trials in Czechia

Peru3 sites

  • Hospital Nacional Arzobispo Loayza

    Lima, 01

  • Hospital Nacional Hipolito Unanue

    Lima, 27

  • Clinica Vesalio

    Lima, 41

Other trials in Peru

About this study

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.

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.

Being tested
Lurasidone, Placebo
Keywords
Bipolar I Depression, Lurasidone, Latuda
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LurasidoneDrug

    Also called Latuda

    Tablets 20-120 mg, PM dosing,daily for 6 weeks

  • PlaceboDrug

    Equivalent to Lurasidone dosing

Study groups in NCT01284517
Study groupRoleWhat they receive
Lurasidone 20-120 mg flexible doseExperimentalNot described
Receives: Drug: Lurasidone
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to week 6

Secondary outcomes (2)

  1. 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.

    Measured: Baseline to week 6

  2. 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.

    Measured: Baseline to week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2011 (estimated)
  2. Study startNov 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
356 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01284517
Sponsor's protocol ID
D1050292
Other IDs
2010-019778-34
Acronym
PREVAIL3
Status last verified
Oct 2013
First submitted
25 Jan 2011
Last updated
26 Nov 2013
Data monitoring committee
Yes

Publications

  • Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.

    PubMed 39098761

  • 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.

    PubMed 27089521

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone in people with Bipolar Depression, run by Sumitomo Pharma America, Inc. at 75 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, India, Slovakia, Ukraine, Japan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Endpoint (Week 6) (time frame: Baseline to week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01284517, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.

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