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Bipolar I DisorderPhase 3PERSISTExtNCT01575561

This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296

A Phase 3 study testing Lurasidone in people with Bipolar I Disorder, run by Sumitomo Pharma America, Inc. at 71 sites in 12 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 an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or… 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
377 participants
Where
71 sitesin 12 countries
Study dates
Jun 2012to Jul 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

  • Subject has agreed to participate by providing written informed consent.
  • Subject has completed the 28 week Double-blind Phase of Study D1050296 and all required assessments on the final study visit (Week 28, Visit 28); OR
  • Subject has experienced a protocol-defined recurrence of any mood event during the Double blind Phase of Study D1050296 and has completed all required assessments on the final study visit; OR
  • Subject had at least entered the Open-label Phase of Study D1050296 when the Sponsor stopped the study and has completed all required assessments on the final study visit.
  • Subject is judged by the Investigator to be suitable for participation in a 12 week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Who cannot join

  • Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
  • Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at the extension baseline visit (final study visit in Study D1050296).

Trial locations and contacts

71 sites in 12 countries.

71 sites in 12 countries

United States25 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30308

  • Florida Clinical Research LLC

    Bradenton, Florida, 34201

  • Carolina Clinical Trials

    Charleston, South Carolina, 29407

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

    Dallas, Texas, 75235

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Charak Clincial Research Center

    Garlield Heights, Ohio, 44125

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • Activ Med Practices & Research

    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

  • Excell Research, Inc

    Oceanside, California, 92056

  • Cutting Edge Research Group

    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, 93404

  • 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, 93405

  • Clinco

    Terre Haute, Indiana, 47802

Other trials in United States

Czechia8 sites

  • Saint Anne, s.r.o., Psychiatricke oddeleni

    Brno - Mesto, 602 00

  • Psychiatricka ambulance

    Havířov, 73601

  • Psychiatricka lecebna U Honzicka

    Písek, 397 01

  • Clintrial s.r.o.

    Prague, 100 00

  • Psychiatricka ambulance

    Prague, 106 00

  • Psychiatricka ambulance

    Prague, 149 00

  • Psychiatricka ambulance Prosek

    Prague, 190 00

  • Telemens, s.r.o.

    Přerov, 750 01

Other trials in Czechia

Argentina6 sites

  • Clinica Privada de Salud Mental Santa Teresa de Avila

    Buenos Aires, 1900

  • Novain Neurociencias Group

    Buenos Aires, C1117ABH

  • Instituto Nacional de Psicopatología (INAPSI)

    Buenos Aires, C1405BOA

  • Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)

    Buenos Aires, C1425AHQ

  • Instituto DAMIC SRL

    Córdoba, 5003

  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

    Rosario, 2000

Other trials in Argentina

Russia6 sites

  • State Healthcare and Forensic Psychiatric Expertise Institution

    Izhevsk, 426054

  • Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"

    Saint Petersburg, 190005

  • St Petersburg State Government Healthcare Institution

    Saint Petersburg, 190121

  • St. Petersburg State Healthcare Institution "City Clinical Hospital #4"

    Saint Petersburg, 191119

  • Mental Health Research Institute of Siberian Branch of RAMS

    Tomsk, 634014

  • Nizhny Novgorod Regional State Institution of Healthcare

    Velikiy Novgorod, 603155

Other trials in Russia

Japan5 sites

  • Yuge Hospital

    Kumamoto, 861-8002

  • Asakayama General Hospital

    Sakai, Osaka

  • Goryokai Medical Corporation

    Sapporo, Hokkaido, 002-8029

  • Nishigahara Hospital

    Tokyo, 114-0024

  • Kawada Hospital

    Toyama, 933-0917

Other trials in Japan

Hungary4 sites

  • Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika

    Budapest, 1125

  • Nyiro Gyula Korhaz, I. Pszichiatria

    Budapest, 1135

  • Nyiro Gyula Korhaz, II. Pszichiatria

    Budapest, 1135

  • Nyiro Gyula Korhaz

    Budapest, 1135

Other trials in Hungary

Serbia4 sites

  • Clinical Hospital Centre Dragisa Misovic

    Belgrade, 11000

  • Clinical Centre Kragujevac, Psychiatric Hospital

    Kragujevac, 34000

  • Clinic for Mental Health Protection, Clinical Centre Nis

    Niš, 18000

  • Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"

    Novi Kneževac, 23330

Other trials in Serbia

Bulgaria3 sites

  • Center for Mental Health

    Rousse, 7003

  • Multiprofiled Hospital for Active Treatment "Alexandrovska"

    Sofia, 1431

  • Military Medical Academy

    Sofia, 1606

Other trials in Bulgaria

France3 sites

  • CHS La Chartreuse - Pôle 6

    Dijon, 21033

  • Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique

    Dole, 39100

  • Centre Hospitalier Régional Universitaire

    Nîmes, 30900

Other trials in France

Poland3 sites

  • NZOZ Syntonia

    Gdynia, 81-361

  • NZOZ BioMed

    Kielce, 25-411

  • NZOZ Prywatna Klinika Psychiatryczna Inventiva

    Tuszyn, 95-080

Other trials in Poland

Chile2 sites

  • Hospital El Pino

    Santiago, 8053095

  • Clinica Pedro Montt

    Santiago, 8330838

Other trials in Chile

Slovakia2 sites

  • Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.

    Rimavská Sobota, 97912

  • Psychiatricka ambulancia

    Zlaté Moravce, 95301

Other trials in Slovakia

About this study

Official title: A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder

This is an open-label, multi-center,12 week extension study designed to evaluate the longer term safety, tolerability and effectiveness of lurasidone, flexibly dosed, adjunctive to lithium or divalproex for the treatment of subjects with bipolar I disorder, who have either completed the core study D1050296 or experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Read the detailed description

To evaluate the longer term safety of lurasidone (20, 40, 60 or 80 mg/day) in subjects with bipolar I disorder.

Subjects will be initially treated with open-label lurasidone 40 mg/day (Day 1).

Dose adjustment of study drug (20, 40, 60 or 80 mg /day) should occur at the regularly scheduled visits and in increments/decrements of 1 dose level.

Being tested
Lurasidone
Keywords
Lurasidone, Latuda, Bipolar Disorder
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

    Lurasidone 20-80 mg taken orally once daily

Study groups in NCT01575561
Study groupRoleWhat they receive
LurasidoneExperimentalLurasidone 20, 40, 60,80 mg flexible dose
Receives: Drug: Lurasidone

What is being measured

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

  1. Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events

    Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation

    Measured: 12 weeks

Secondary outcomes (8)

  1. Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) 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: baseline, 12 weeks (LOCF)

  2. Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) 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: baseline, 12 weeks (LOCF)

  3. Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)

    Movement disorders as assessed by Young Mania Rating Scale (YMRS) 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 mania.

    Measured: Baseline, 12 weeks (LOCF)

  4. Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

    Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -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 depression.

    Measured: baseline ,Week 12 (LOCF)

  5. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)

    Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -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: baseline, week 12 (LOCF)

  6. Change From Baseline to Week 12 (LOCF) in the 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 higher score is associated with greater illness severity

    Measured: baseline, week 12 (LOCF)

  7. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale

    The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range 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: baseline, week 12 (LOCF)

  8. Change From Baseline to Week 12 (LOCF) in the 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: baseline, week 12 (LOCF)

Timeline

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

  1. First posted11 Apr 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionJul 2015
  4. Study completionJul 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01575561
Sponsor's protocol ID
D1050308
Other IDs
2011-004789-14
Acronym
PERSISTExt
Status last verified
Jul 2016
First submitted
28 Mar 2012
Last updated
22 Aug 2016
Data monitoring committee
No

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 71 sites in 12 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 5 inclusion and 2 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 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Czechia, Argentina, Russia, Japan and 7 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. 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 22 Aug 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?

Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events (time frame: 12 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 NCT01575561.

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 22 Aug 2016.

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