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Bipolar I DisorderPhase 3PERSISTNCT01358357

Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

A Phase 3 study testing Lurasidone in people with Bipolar I Disorder, run by Sumitomo Pharma America, Inc. at 105 sites in 14 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

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar I Disorder
What is being tested?
Lurasidone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
965 participants
Where
105 sitesin 14 countries
Study dates
Jun 2011to Apr 2015
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Open-label Phase
  • 18 years of age or older
  • Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder
  • •≥ 1 manic, mixed manic, or depressed episode in past 2 years
  • YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex
  • Double-blind Phase
  • Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization

Who cannot join

  • Open Label Phase
  • Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
  • Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
  • Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
  • Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
  • Unstable/inadequately treated medical illness
Show all 11Show fewer
  • The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)
  • Double Blind Phase
  • Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
  • Subjects who have not stabilized during the open-label phase (within 20 weeks)
  • Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study

Trial locations and contacts

105 sites in 14 countries.

105 sites in 14 countries

United States26 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Florida Clinical Research LLC

    Bradenton, Florida, 34201

  • Carolina Clinical Trials, Inc.

    Charleston, South Carolina, 29407

  • Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Charak Center for Health and Wellness

    Garfield Heights, Ohio, 44125

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • ActivMed Practices & Research Inc.

    Haverhill, Massachusetts, 08130

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32216

  • R/D Clinical Research, Inc.

    Lake Jackson, Texas, 77566

  • Lincoln Research

    Lincoln, Rhode Island, 02865

  • AXIS Clinical Trials

    Los Angeles, California, 90036

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119

  • Galiz Research

    Miami Springs, Florida, 33166

  • Village Clinical Research Inc,

    New York, New York, 10003

  • Excell Research, Inc.

    Oceanside, California, 92056

  • Cutting Edge Research Groupd

    Oklahoma City, Oklahoma, 73116

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32806

  • Stanford University School of Medicine Research Program VA Palo Alto Health Care System

    Palo Alto, California, 94304

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • SF-CARE, Inc.

    San Francisco, California, 94117

  • Neuropsychiatric Research Center of Orange County

    Santa Ana, California, 92701

  • Psych Care Consultants Research

    St Louis, Missouri, 63128

  • "Stanford University School of Medicine

    Stanford, California, 94305

  • Clinco

    Terre Haute, Indiana, 47802

Other trials in United States

Japan13 sites

  • Okehazama Hospital Fujita Kokoro Care Center

    Aichi, 470-1168

  • Ongata Hospital

    Hachioji, Tokyo

  • National Hospital Organization Hizen Psychiatric Center

    Kanzaki, Saga-ken, 842-0192

  • Nishigahara Hospital

    Kita-ku, Tokyo, 114-0024

  • Nagano Prefectural Mental Wellness Center-Komagane

    Komagane, Nagano

  • Yuge Hospital

    Kumamoto, 861-8002

  • Shonan Hospital

    Matsumoto-shi, Nagano, 390-0847

  • Arakaki Hospital

    Okinawa, 904-0012

  • Asakayama General Hospital

    Sakai, Osaka

  • Goryokai Medical Corporation

    Sapporo, Hokkaido, 002-8029

  • Sapporokousetsu Hospital

    Sapporo, Hokkaido

  • Haruna Hospital

    Shibukawa, Gunma

  • Kawada Hospital

    Toyama, 933-0917

Other trials in Japan

Czechia11 sites

  • Saint Anne s.r.o.

    Brno, 602 00

  • Fakultni Nemocnice Brno

    Brno-Bohunice, 62500

  • Psychiatricka ambulance

    Havířov, 736 01

  • Psychiatricka Iecebna U Honzicka

    Písek, 397 01

  • Clintrial s.r.o.

    Prague, 100 00

  • Psychiatricka Ambulance

    Prague, 10600

  • Psychiaricka ambulance

    Prague, 140 00

  • Psychiatricka ambulance Prosek

    Prague, 190 00

  • Psychiatricke Centrum Praha

    Prague 8-Bohunice, 62500

  • Psychosocialni Centrum

    Přerov, 75001

  • Psychiatricka ambulance

    Ústí nad Labem, 401 13

Other trials in Czechia

Argentina8 sites

  • Novain Neurociencias Group

    Buenos Aires, C1117ABH

  • Centro de Neuropsiquiatria

    Buenos Aires, C1425AHQ

  • IPEM-Instituto de Prevención de las Enfermedades Mentales.

    Buenos Aires

  • Sanatorio Morra

    Córdoba, Córdoba Province, 5009

  • Instituto DAMCI

    Córdoba, 5009

  • Clinica Privada de Salud Mental Santa Teresa de Avila

    La Plata, 1900

  • Centro de Psiquiatria Biologica

    Mendoza, 5500

  • Centro de Atencion E Invest. Clinica (CAICI)

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

Hungary7 sites

  • Obudai Egeszsegugyi Centurm Kft.

    Budapest, 1036

  • Fovarosi Onkormanyzat Szent Istvan Korhaz es Szent Laszlo Korhaz

    Budapest, 1096

  • Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

    Budapest, 1125

  • Nyiro Gyula Korhaz

    Budapest, 1135

  • Fovarosi Onkormanyzat Nyiro Gyula Korhaz, I. Pszichiatria

    Budapest, H-1135

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaz

    Gyula, 5700

Other trials in Hungary

Bulgaria6 sites

  • Psychiatry Dispensary

    Burgas, 80000

  • University Multiprofiled Hospital for Active Treatment "Sveti Georgi"

    Plovdiv, 4002

  • Regional Psychiatric Dispensary

    Rousse, 7003

  • Multiprofiled Hospital for Active Treatment "Alexandrovska"

    Sofia, 1431

  • Psychiatric Clinic, Military Medical Academy

    Sofia, 1606

  • Multprofiled Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

Other trials in Bulgaria

Russia6 sites

  • State Healthcare and Forensic Psychiatric Expertise Institution

    Izhevsk, 462054

  • Nizhny Novgorod Regional State Institution of Healthcare

    Nizhny Novgorod, 603155

  • St. Petersburg State Healthcare Institution (SPSHI)

    Saint Petersburg, 190005

  • St.Petersburg State Healthcare Institution (SPSHI)

    Saint Petersburg, 190005

  • St Petersburg State Government Healthcare Institution

    Saint Petersburg, 190121

  • Mental Health Research Institute of Rams

    Tomsk, 634050

Other trials in Russia

Croatia5 sites

  • Clinic Hospital Centre Rijeka Clinic for Psychiatry

    Rijeka, 51000

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000

  • Klinicki Bolnicki Centar Zagreb-Rebro

    Zagreb, 10000

  • University Hospital Sestremilosrdnice

    Zagreb

  • University Hospital Centre Zagreb

    Zagreg, 10000

Other trials in Croatia

Poland5 sites

  • NZOZ Syntonia

    Gdynia, 81-361

  • NZOZ BioMed

    Kielce, 25411

  • Wojewodzki Osrodek Lexznictwa Psychiatrycznego w Toruniu

    Torun, 87-100

  • Prywatny Gabinet Lekarski Jaroslaw Strzelec

    Tuszyn, 95-080

  • Przychodnia Lekarsko-Psychologiczna "Persona" Spolka Partnerska Lekarzy

    Wroclaw, 50-227

Other trials in Poland

Serbia5 sites

  • Clinical Centre of Serbia

    Belgrade, 11000

  • Clinical Hospital Centre Dragisa Misovic

    Belgrade, 11000

  • Psychiatric Clinic Clinical Center Kragujevac

    Kragujevac, 34000

  • Clinical Centre Nis

    Niš, 18000

  • Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

    Novi Kneževac, 23330

Other trials in Serbia

Australia4 sites

  • The Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Hollywood Medical Centre

    Fremantle, Western Australia, 6160

  • RWF Medic Pty Ltd as Trustee for Farnbach Family Trust at Neurotherapy Victoria

    Malvern, Victoria, 3144

  • The Melbourne Clinic

    Richmond, Victoria, 3121

Other trials in Australia

France4 sites

  • CHS La Chartreuse-Pole 6

    Dijon, 21033

  • Centre Hospitalier Specialise du Jura-Centre Medico Psychiatrique

    Dole, 39100

  • Hopital Lapeyronie

    Montpellier, 34295

  • CHRU de Nimes, Service de Psychiatrie adulte

    Nîmes, 30029

Other trials in France

Chile3 sites

  • CETEP

    Santiago, 27014

  • Clinica Las Condes

    Santiago, 27014

  • Psicomedica

    Santiago, 27014

Other trials in Chile

Slovakia2 sites

  • Vseobecna Nemocnica Rimavska Sobota, NaP, n.o. Bratislava

    Rimavská Sobota, 97912

  • Psychiatricka ambulancia

    Zlaté Moravce, 95301

Other trials in Slovakia

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Flexible-dose, Parallel-group Study of Lurasidone Adjunctive to Lithium or Divalproex for the Prevention of Recurrence in Subjects With Bipolar I Disorder

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

Read the detailed description

This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

Being tested
Lurasidone, Placebo
Keywords
Lurasidone, Latuda, Bipolar I

What participants receive

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

  • LurasidoneDrug

    Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter

  • PlaceboDrug

    20-80 mg flexible dose

Study groups in NCT01358357
Study groupRoleWhat they receive
Lurasidone 20-80 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. Time to Recurrence of Mood Event During the Double Blind Treatment Phase

    A mood event is defined as one of the following during the double-blind phase:

    (1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator).

    Measured: 28 weeks (up to 33 weeks)

Secondary outcomes (13)

  1. Time to All-cause Discontinuation

    Measured: 28 weeks (up to 33 weeks)

  2. Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode

    Measured: 28 weeks (up to 33 weeks)

  3. Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode

    Measured: 28 weeks

  4. Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score

    The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity.

    Measured: Double-blind Baseline to week 28

  5. Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score

    The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity

    Measured: Double-blind Baseline to week 28

  6. Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score

    The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity.

    Measured: Double-blind Baseline to week 28

  7. Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score

    the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia.

    Measured: Double-blind Baseline to week 28

  8. Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score

    The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms.

    Measured: Double-blind Baseline to week 28

  9. Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score

    The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.

    Measured: Double-blind Baseline to week 28

  10. Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score

    The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.

    Measured: Double-blind Baseline to week 28

  11. Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score

    The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.

    Measured: Double-blind Baseline to week 28

  12. Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score

    The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia.

    Measured: Double-blind Baseline to week 28

  13. Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score

    The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score - 14 [Minimum Score]) / (70 [Maximum Score] - 14 [Minimum Score]). Higher percent maximum scores indicate better quality of life.

    Measured: Double-blind Baseline to week 28

Timeline

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

  1. First posted23 May 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

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
965 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01358357
Sponsor's protocol ID
D1050296
Other IDs
2011-000986-10
Acronym
PERSIST
Status last verified
Jul 2016
First submitted
19 May 2011
Last updated
7 Sep 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lurasidone in people with Bipolar I Disorder, run by Sumitomo Pharma America, Inc. at 105 sites in 14 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 11 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 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Japan, Czechia, Argentina, Hungary and 9 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 26 Jul 2016). 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?

Time to Recurrence of Mood Event During the Double Blind Treatment Phase (time frame: 28 weeks (up to 33 weeks)). 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 NCT01358357.

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 7 Sep 2016.

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