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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 (PERSISTExt)

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ClinicalTrials.gov Identifier: NCT01575561
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : August 22, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief 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 experienced a protocol defined recurrence of a mood event in the double-blind phase of the core study D1050296

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Lurasidone Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open Label, Flexible Dose, Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects With Bipolar I Disorder
Study Start Date : June 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Lurasidone

Arm Intervention/treatment
Experimental: Lurasidone
Lurasidone 20, 40, 60,80 mg flexible dose
Drug: Lurasidone
Lurasidone 20-80 mg taken orally once daily




Primary Outcome Measures :
  1. Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events [ Time Frame: 12 weeks ]
    Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation


Secondary Outcome Measures :
  1. Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score [ Time Frame: baseline, 12 weeks (LOCF) ]
    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.

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

  3. Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, 12 weeks (LOCF) ]
    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.

  4. Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline ,Week 12 (LOCF) ]
    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.

  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) [ Time Frame: baseline, week 12 (LOCF) ]
    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.

  6. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score [ Time Frame: baseline, week 12 (LOCF) ]
    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

  7. Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale [ Time Frame: baseline, week 12 (LOCF) ]
    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.

  8. Change From Baseline to Week 12 (LOCF) in the SDS Total Score [ Time Frame: baseline, week 12 (LOCF) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575561


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Locations
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United States, Alabama
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
United States, California
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
AXIS Clinical Trials
Los Angeles, California, United States, 90036
Excell Research, Inc
Oceanside, California, United States, 92056
Stanford University School of Medicine Research Program VA Palo Alto Health Care System
Palo Alto, California, United States, 93404
SF-Care, Inc.
San Francisco, California, United States, 94117
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701
Stanford University School of Medicine
Stanford, California, United States, 93405
United States, Florida
Florida Clinical Research LLC
Bradenton, Florida, United States, 34201
Clinical Neuroscience Solutions Inc.
Jacksonville, Florida, United States, 32216
Galiz Research
Miami Springs, Florida, United States, 33166
Clinical Neuroscience Solutions
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30308
United States, Indiana
Clinco
Terre Haute, Indiana, United States, 47802
United States, Massachusetts
Activ Med Practices & Research
Haverhill, Massachusetts, United States, 08130
United States, Missouri
Psych Care Consultants Research
St. Louis, Missouri, United States, 63128
United States, New York
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
United States, Ohio
Charak Clincial Research Center
Garlield Heights, Ohio, United States, 44125
United States, Oklahoma
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Suburban Research Associates
Media, Pennsylvania, United States, 19063
United States, Rhode Island
Lincoln Research
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Carolina Clinical Trials
Charleston, South Carolina, United States, 29407
United States, Tennessee
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Psychoneuroendocrinology Research Group, Dept of Psychiatry, UT Southwestern Medical Center
Dallas, Texas, United States, 75235
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Argentina
Clinica Privada de Salud Mental Santa Teresa de Avila
Buenos Aires, Argentina, 1900
Novain Neurociencias Group
Buenos Aires, Argentina, C1117ABH
Instituto Nacional de Psicopatología (INAPSI)
Buenos Aires, Argentina, C1405BOA
Fundacion para el estudio y tratamiento de las enfermedades mentales (FETEM)
Buenos Aires, Argentina, C1425AHQ
Instituto DAMIC SRL
Cordoba, Argentina, 5003
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
Rosario, Argentina, 2000
Bulgaria
Center for Mental Health
Rousse, Bulgaria, 7003
Multiprofiled Hospital for Active Treatment "Alexandrovska"
Sofia, Bulgaria, 1431
Military Medical Academy
Sofia, Bulgaria, 1606
Chile
Hospital El Pino
Santiago, Chile, 8053095
Clinica Pedro Montt
Santiago, Chile, 8330838
Czech Republic
Saint Anne, s.r.o., Psychiatricke oddeleni
Brno - mesto, Czech Republic, 602 00
Psychiatricka ambulance
Havirov, Czech Republic, 73601
Psychiatricka lecebna U Honzicka
Pisek, Czech Republic, 397 01
Psychiatricka ambulance
Prague, Czech Republic, 149 00
Clintrial s.r.o.
Praha, Czech Republic, 100 00
Psychiatricka ambulance
Praha, Czech Republic, 106 00
Psychiatricka ambulance Prosek
Praha, Czech Republic, 190 00
Telemens, s.r.o.
Prerov, Czech Republic, 750 01
France
CHS La Chartreuse - Pôle 6
Dijon cedex, France, 21033
Centre Hospitalier Spécialisé du Jura - Centre Médico Psychiatrique
Dole, France, 39100
Centre Hospitalier Régional Universitaire
Nimes, France, 30900
Hungary
Kutvolgyi Klinikai Tomb SOTE IIIsz Belgyogyaszati Klinika
Budapest, Hungary, 1125
Nyiro Gyula Korhaz, I. Pszichiatria
Budapest, Hungary, 1135
Nyiro Gyula Korhaz, II. Pszichiatria
Budapest, Hungary, 1135
Nyiro Gyula Korhaz
Budapest, Hungary, 1135
Japan
Goryokai Medical Corporation
Sapporo-shi, Hokkaido, Japan, 002-8029
Asakayama General Hospital
Sakai, Osaka, Japan
Yuge Hospital
Kumamoto, Japan, 861-8002
Nishigahara Hospital
Tokyo, Japan, 114-0024
Kawada Hospital
Toyama, Japan, 933-0917
Poland
NZOZ Syntonia
Gdynia, Poland, 81-361
NZOZ BioMed
Kielce, Poland, 25-411
NZOZ Prywatna Klinika Psychiatryczna Inventiva
Tuszyn, Poland, 95-080
Russian Federation
State Healthcare and Forensic Psychiatric Expertise Institution
Izhevsk, Russian Federation, 426054
Nizhny Novgorod Regional State Institution of Healthcare
Novgorod, Russian Federation, 603155
St Petersburg State Government Healthcare Institution
St Petersburg, Russian Federation, 190121
Saint Petersburg State Healthcare Institution "City psycho-neurology Dispanser #7"
St. Petersburg, Russian Federation, 190005
St. Petersburg State Healthcare Institution "City Clinical Hospital #4"
St. Petersburg, Russian Federation, 191119
Mental Health Research Institute of Siberian Branch of RAMS
Tomsk, Russian Federation, 634014
Serbia
Clinical Hospital Centre Dragisa Misovic
Belgrade, Serbia, 11000
Clinical Centre Kragujevac, Psychiatric Hospital
Kragujevac, Serbia, 34000
Clinic for Mental Health Protection, Clinical Centre Nis
Nis, Serbia, 18000
Specialized Hospital for Psychiatric Diseased "Sveti Vracevi"
Novi Knezevac, Serbia, 23330
Slovakia
Psychiatricke oddelenie, Vseobecna nemocnica Rimavska Sobota NaP n.o.
Rimavska Sobota, Slovakia, 97912
Psychiatricka ambulancia
Zlate Moravce, Slovakia, 95301
Sponsors and Collaborators
Sunovion
Investigators
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Study Director: Lurasidone Medical Director, MD Sunovion

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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01575561     History of Changes
Other Study ID Numbers: D1050308
2011-004789-14 ( EudraCT Number )
First Posted: April 11, 2012    Key Record Dates
Results First Posted: August 22, 2016
Last Update Posted: August 22, 2016
Last Verified: July 2016
Keywords provided by Sunovion:
Lurasidone
Latuda
Bipolar Disorder
Additional relevant MeSH terms:
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Disease
Pathologic Processes
Lurasidone Hydrochloride
Psychotropic Drugs
Molecular Mechanisms of Pharmacological Action
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents