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A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

Sponsor
Sunovion (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04115319
Collaborator
(none)
300
Enrollment
46
Locations
2
Arms
37.8
Anticipated Duration (Months)
6.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.

This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

This is a 52-week, multicenter, randomized, double-blind, parallel-group, flexible-dose study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) compared with quetiapine XR (400 to 800 mg/day) in clinically stable adult subjects with schizophrenia. This study is projected to randomize a least 300 subjects to two treatment groups (SEP-363856 50 to 100 mg/day or quetiapine XR 400 to 800 mg/day) in a 2:1 ratio. Study drug will be taken once a day and may be taken without food or with a light meal.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Randomized, Double-blind, Active Comparator-Controlled StudyA Randomized, Double-blind, Active Comparator-Controlled Study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Actual Study Start Date :
Nov 15, 2019
Anticipated Primary Completion Date :
Jan 10, 2023
Anticipated Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SEP363856

SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule

Drug: SEP363856
SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
Active Comparator: quetiapine XR

quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Drug: quetiapine XR
quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
Other Names:
  • Seroquel XR

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation [52 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    The main inclusion criteria include, but are not limited to the following:

    • Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.

    • Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening.

    • Subject must have a CGI-S score ≤ 4 at Screening and Baseline.

    • Subject must have a PANSS total score ≤ 80 at Screening and Baseline.

    • Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.

    • Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.

    • Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).

    • Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).

    Exclusion criteria:
    Main exclusion criteria include, but are not limited to:

    • Subject was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.

    • Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, schizoaffective disorder, ,bipolar I or II disorder, obsessive compulsive disorder, and posttraumatic stress disorder, symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as theses symptoms are not the primary focus of treatment.

    • Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks.

    • 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 C-SSRS assessment at Screening (i.e., in the past one month) or at Baseline (i.e., since last visit).

    • Subject is at significant risk of harming self or others based on Investigator's judgment.

    • Subject has attempted suicide within 6 months prior to Screening.

    • Subject has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer)

    • Subject has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR.

    • Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.

    • Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Synexus Clinical Research US, Inc. Cerritos California United States 90703
    2 Pacific Research Partners Oakland California United States 94607
    3 Excell Research Oceanside California United States 92056
    4 Artemis Institute for Clinical Research San Diego California United States 92103
    5 Collaborative Neuroscience Network Torrance California United States 90502
    6 Innovative Clinical Research Miami Lakes Florida United States 33016
    7 Premier Clinical Research Institute Miami Florida United States 33122
    8 Synexus Clinical Research US Atlanta Georgia United States 30328
    9 Alexian Brothers Center for Psychiatric Research Hoffman Estates Illinois United States 60169
    10 Pillar Clinical Research Lincolnwood Illinois United States 60712
    11 Louisiana Clinical Research Shreveport Louisiana United States 71101
    12 PsychCare Consultants Research Saint Louis Missouri United States 63128
    13 Dean-Yurie, Altea Research Las Vegas Nevada United States 89102
    14 Krzsztof Wroblewi-Neurobehavioral Research Inc. Cedarhurst New York United States 11516
    15 Tyne Moeller-Synexus Clinical Research US Inc. Jamaica New York United States 11432
    16 Finger Lakes Clinical Research Rochester New York United States 14618
    17 New Hope Clinical Research Charlotte North Carolina United States 28211
    18 Dr. Shishuka Malhorta North Canton Ohio United States 44720
    19 Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu, Brasov Romania 500079
    20 Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie Brasov Romania 500079
    21 Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII Bucuresti Romania 041914
    22 Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Bucuresti Romania 060222
    23 Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII Bucuresti Romania 41914,
    24 Institutul de Psihiatrie Socola Iasi Iasi Romania 700282
    25 State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital" Arkhangelsk Russian Federation 163530
    26 State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital" Ekaterinburg Russian Federation 620030
    27 Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko" Leningrad Russian Federation 188357
    28 State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital" Moscow Russian Federation 127083
    29 Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov" Omsk Russian Federation 644070
    30 Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets" Saint Petersburg Russian Federation 190121
    31 Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF Saint Petersburg Russian Federation 192019
    32 Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" Saint Petersburg Russian Federation 192019
    33 Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5" Saint Petersburg Russian Federation 195176
    34 Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1" Saint Petersburg Russian Federation 199106
    35 FSBEI HE "Smolensk State Medical University" of the MoH of the RF leg add: 28, Krupskoi str, Smolensk, Smolensk region, 214019; act add: 46-a, Kirova str, Smolensk Smolensk Russian Federation 214031
    36 S St-Petersburg state budget institution Psychoneurological dispensary #10 St-Petersburg Russian Federation 190121
    37 State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2" Stavropol Russian Federation 357034
    38 LLC "Clinic Stolet" 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI "Tomsk National Research Medical Center of Russian Academy of Sciences" Tomsk Russian Federation 634014
    39 State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital" Yaroslavl Russian Federation 150003
    40 Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8 Ivano-Frankivsk Ukraine 76011
    41 State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry Kharkiv Ukraine 61068
    42 State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology Kharkiv Ukraine 61068
    43 Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic Kyiv Ukraine 03049
    44 Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12 Smila Ukraine 20708
    45 Communal Non-commercial Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Psychiatry #2 (male), Department of Psychiatry #6 (female), Ternopil I.Ya. Gorbachevskyi National Medical University of t Ternopil Ukraine 46027
    46 Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry Uzhgorod Ukraine 88000

    Sponsors and Collaborators

    • Sunovion

    Investigators

    • Study Chair: CNS Medical Director, Sunovion

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sunovion
    ClinicalTrials.gov Identifier:
    NCT04115319
    Other Study ID Numbers:
    • SEP361-304
    • 2019-002259-40
    First Posted:
    Oct 4, 2019
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sunovion
    schizophrenia
    Additional relevant MeSH terms:
    Schizophrenia
    Quetiapine Fumarate

    Study Results

    No Results Posted as of Feb 17, 2022