A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia

NCT02969382 | Completed Phase 2 Results

• 2 other identifiers: SEP361-2012016-001555-41
• Study Type: interventional
• Target: 245
• Locations: 5 countries
• Sites: 33

Brief Summary

A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

  PANSS comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). 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. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210. Higher PANSS total score means more severe outcome.

  Baseline, Week 4

Secondary Outcomes (11)

• Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4

  Baseline, Week 4

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score at Week 4

  Baseline, Week 4

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score at Week 4

  Baseline, Week 4

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 4

  Baseline, Week 4

• Change From Baseline in Brief Negative Symptom Scale (BNSS) Total Score at Week 4

  Baseline, Week 4

Study Arms (2)

SEP-363856

EXPERIMENTAL

SEP-363856 capsule (50 mg or 75 mg) once daily

Drug: SEP-363856

Placebo

PLACEBO COMPARATOR

Placebo capsule once daily

Drug: Placebo - Cap

Interventions

SEP-363856 DRUG

One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks

SEP-363856

Placebo - Cap DRUG

One Placebo capsule daily for 4 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject must give written informed consent and privacy authorization prior to participation in the study. Separate consent will be obtained from a caregiver or legal guardian if required by local law.
• Subject must be willing and able to comply with the study procedures and visit schedules, including required hospitalization for the washout period and the double-blind treatment period, and must be able to understand and follow verbal and written instructions.
• Male or female subject between 18 to 40 years of age (inclusive) at the time of consent.
• Subject meets DSM-5 criteria for schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the SCID-CT). The duration of the subject's illness whether treated or untreated must be ≥ 6 months.
• Subject must have a CGI-S score ≥ 4 (moderate or greater) at screening and Baseline (Day 1).
• Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 (moderate) on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content at screening and Baseline (Day 1).
• Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months).
• Subject has marked deterioration of functioning in one or more areas, such as occupational, social, or personal care or hygiene.
• Subject requires hospitalization for an acute psychotic exacerbation at the time of screening or has been hospitalized for the purpose of treating an acute psychotic exacerbation for no more than 2 consecutive weeks immediately before screening.
• Subjects who have been hospitalized for more than 2 weeks for reasons unrelated to an acute psychotic exacerbation may be included if such a hospitalization was for a condition other than an acute psychotic relapse. For example, subjects in a long-term hospital setting who have an acute exacerbation and are transferred to an acute unit are eligible for the study.
• Subject has had no more than 2 prior hospitalizations for the treatment of an acute exacerbation of schizophrenia (not including the current hospitalization) This history must be confirmed based on report by a reliable informant (eg., caregiver or family member) or medical records available at the time of screening.
• Subject's BMI must be at least 18 kg/m2 but no more than 35 kg/m2.
• Female subject must have a negative serum pregnancy test at screening.11. Female subject of reproductive potential agrees to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug has been taken. In the Investigator's judgment, the subject will adhere to this requirement.
• Adequate contraception is defined as continuous use of either two barrier methods (eg, condom and spermicide or diaphragm with spermicide) or a hormonal contraceptive.
• Acceptable hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®) implanted at least 90 days prior to screening; b) injectable contraception (such as medroxyprogesterone acetate injection) given at least 14 days prior to screening; or c) oral contraception taken as directed for at least 30 days prior to screening.

You may not qualify if:

• \. 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 or during the Screening period (ie, in the past one month) and/or at Baseline (ie, since last visit).
• \. Subject does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
• \. Subject is currently participating, or has participated in, a study with an investigational or marketed compound or device within 6 months prior to signing the informed consent, or has participated in 2 or more studies within 24 months prior to signing informed consent.
• \. Subject has previously received SEP-363856. 5. 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:
• Hematological (including deep vein thrombosis) or bleeding disorder, renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular, hepatic, neurologic, or allergic disease that is clinically significant or unstable (except for untreated, asymptomatic, seasonal allergies at time of dosing).
• Subject has a history of neuroleptic malignant syndrome. Protocol SEP361-201, Version 3.01 SEP-363856 Confidential and Proprietary 37 17 August 2017
• Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
• Disorder or history of a condition, or previous gastrointestinal surgery (eg, cholecystectomy, vagotomy, bowel resection, or any surgical procedure) that may interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal motility, or pH, or a clinically significant abnormality of the hepatic or renal system, or a history of malabsorption.
• Subject has Alcohol or Substance Abuse Disorder (DSM-5 criteria). The only exceptions include caffeine or nicotine.
• Subject has a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete the study or a screening 12-lead ECG demonstrating any one of the following: heart rate \> 100 beats per minute, QRS \> 120 ms, QT interval corrected for heart rate using Fridericia's formula (QTcF) \> 450 ms (males), QTcF \> 470 ms (females), or PR \> 220 ms.
• Subjects with known history of human immunodeficiency virus (HIV) seropositivity.6. 6. Female subject who is pregnant or lactating.
• \. Subject is at significant risk of harming self, others or objects based on the Investigator's judgment.
• \. Subject has attempted suicide within 3 months prior to screening. 11. Subject is involuntarily hospitalized. 12. Subject has received depot antipsychotics unless the last injection was at least one treatment cycle or at least 30 days (whichever is longer), prior to the screening phase.
• \. Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents, given at adequate dose for at least 4 weeks within a 1 year period prior to Screening.
• \. Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of Screening.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (33)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

California Neuropsychopharmacology Clinical Research Institute-LA, LLC(CNRI- LA, LLC)

Pico Rivera, California, 90660, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

Rehabilitacios Elmegyogyaszati osztaly

Gyöngyös, 3200, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

Gyula, 5700, Hungary

Location

Unknown Facility

Bucharest, 010825, Romania

Location

Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian" - C.E.T.T.T. "Sf. Stelian"

Bucharest, 060222, Romania

Location

Spitalul Clinic de Neuropsihiatrie Craiova

Craiova, 200473, Romania

Location

Institutul de Psihiatrie Socola Iasi, Sectia Clinica III Acuti, Sos. Bucium

Iași, 700282, Romania

Location

State Budgetary Institution of Republic Karelia "Republican Psychiatric Hospital"

Matrosy, Republic Karelia, 186131, Russia

Location

Federal State Budgetary Scientific Instittuion "Scientific Center of Mental Health

Moscow, 115522, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital #1 named after P.P. Kashchenko"

Saint Petersburg, 188357, Russia

Location

City Psychiatric Hospital of St. Nikolay Chudotvorets

Saint Petersburg, 190121, Russia

Location

FSBI Saint Petersburg Scientifc and Research Psychoneurological Instatitute named after V.M Bekhterev

Saint Petersburg, 192019, Russia

Location

SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"

Saint Petersburg, 197341, Russia

Location

300173524

Saint Petersburg, 198020, Russia

Location

300151369

Saratov, 410060, Russia

Location

SBEI HPE "Smolensk State Medical University" of the MoH of the RF

Smolensk, 214019, Russia

Location

300195230

Yekaterinburg, 620030, Russia

Location

Ch of Psychiatry, Narcology and Med Psychol

Ivano-Frankivsk, 76014, Ukraine

Location

Dept of Crisis Cond & Primary Psych Episode #1

Ivano-Frankivsk, 76014, Ukraine

Location

Psychiatric Department of Primary Psychotic Episodes

Kharkiv, 61068, Ukraine

Location

Unit of Emergency Psychiatry and Narcology

Kharkiv, 61068, Ukraine

Location

Dept of Psychiarty #3 (male) and #10 (female)

Kherson, 73488, Ukraine

Location

TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

Kyiv, 04080, Ukraine

Location

CI Odesa Regional Medical Center of Mental Health

Odesa, 65006, Ukraine

Location

Femal Dept #11, Male Dept #12

Smila, 20708, Ukraine

Location

Ch of Neurology, Psychiatry, Narcology and MP

Ternopil, 46020, Ukraine

Location

Dept of Psychiatry

Uzhhorod, 88000, Ukraine

Location

Ch of Psychiatry and Narcology

Vinnytsia, 21005, Ukraine

Location

Related Publications (2)

• Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.

  PMID: 36369028 DERIVED

• Koblan KS, Kent J, Hopkins SC, Krystal JH, Cheng H, Goldman R, Loebel A. A Non-D2-Receptor-Binding Drug for the Treatment of Schizophrenia. N Engl J Med. 2020 Apr 16;382(16):1497-1506. doi: 10.1056/NEJMoa1911772.

  PMID: 32294346 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals, Inc.

CLINICALTRIALDISCLOSURE@SUNOVION.COM

1-866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 21, 2016
• Study Start: December 5, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: July 5, 2024
• Results First Posted: September 22, 2021

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

UA (11); HU (2); US (6); RO (4); RU (10)