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A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SEP-363856
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: This list is not all inclusive Male or female subject between 18 to 65 years of age. Subject meets DSM-5 criteria for a diagnosis of schizophrenia. Subject is judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline. Subject must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy. Subject is taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening. Exclusion Criteria:This list is not all inclusive Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment. Subject is at significant risk of harming self or others based on investigator's judgment. 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. Female subject who is pregnant or lactating. Subject tests positive for drugs of abuse at Screening.

Sites / Locations

  • Advanced Research Center, Inc.Recruiting
  • Clinical Innovations Inc.Recruiting
  • ProScience Research GroupRecruiting
  • Collaborative Neuroscience Research, LLCRecruiting
  • Synergy San DiegoRecruiting
  • Clinical Innovations, IncRecruiting
  • California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)Recruiting
  • CMB Clinical TrialsRecruiting
  • Cenexel CNS ResearchRecruiting
  • Larkin Behavioral Health ServicesRecruiting
  • Behavioral Clinical Research, IncRecruiting
  • Premier Clinical Research Institute, Inc.Recruiting
  • Nova Psychiatry, Inc.Recruiting
  • Advanced Discovery Research LLCRecruiting
  • Atlanta Center for Medical ResearchRecruiting
  • Atlanta Behavioral ResearchRecruiting
  • Uptown ResearchRecruiting
  • CBH HealthRecruiting
  • PsychCare Consultants ResearchRecruiting
  • Hassman Research InstituteRecruiting
  • New Hope Clinical ResearchRecruiting
  • Clinical Trials of America, LLCRecruiting
  • Charak Clinical Research CenterRecruiting
  • Pillar Clinical Research, LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SEP-363856

Arm Description

SEP-363856 flexibly dosed

Outcomes

Primary Outcome Measures

Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy)

Secondary Outcome Measures

Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation)

Full Information

First Posted
November 16, 2022
Last Updated
June 28, 2023
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05628103
Brief Title
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
Official Title
An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
July 24, 2024 (Anticipated)
Study Completion Date
July 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A clinical study that will evalute how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants, ages of 18 years to 65 years, with schizophrenia. The study will take place in approxmiately 24 study sites in North America. Particpants should expect to be in the study for up to 12 weeks.
Detailed Description
This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study designed to evaluate the safety and tolerability, as well as effectiveness of switching clinically stable adult subjects with schizophrenia from a typical or atypical antipsychotic to SEP-363856. This study is projected to enroll approximately 120 subjects into a single treatment group (SEP-363856).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SEP-363856
Arm Type
Experimental
Arm Description
SEP-363856 flexibly dosed
Intervention Type
Drug
Intervention Name(s)
SEP-363856
Intervention Description
SEP-363856 flexibly dosed
Primary Outcome Measure Information:
Title
Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy)
Time Frame
Up to Week 12
Secondary Outcome Measure Information:
Title
Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation)
Time Frame
Up to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: This list is not all inclusive Male or female subject between 18 to 65 years of age. Subject meets DSM-5 criteria for a diagnosis of schizophrenia. Subject is judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline. Subject must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy. Subject is taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening. Exclusion Criteria:This list is not all inclusive Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment. Subject is at significant risk of harming self or others based on investigator's judgment. 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. Female subject who is pregnant or lactating. Subject tests positive for drugs of abuse at Screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CNS Medical Director
Phone
1-866-503-6351
Email
ClinicalTrialDisclosure@sunovion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sumitomo Pharma America, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Austina Cho, MD
Phone
714-999-6688
Facility Name
Clinical Innovations Inc.
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Bota, MD
Phone
562-748-4999
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Bussel
Phone
424-227-8127
Facility Name
Collaborative Neuroscience Research, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Walling
Phone
714-799-7799
Facility Name
Synergy San Diego
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Bari
Phone
619-303-6130
Facility Name
Clinical Innovations, Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald A Maguire, MD
Phone
951-300-4924
Facility Name
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Benbow, MD
Phone
619-481-5252
Facility Name
CMB Clinical Trials
City
Santee
State/Province
California
ZIP/Postal Code
92071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yashwant S Chaudhri
Phone
909-423-0367
Facility Name
Cenexel CNS Research
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Shirikjian, DO
Phone
310-523-4200
Facility Name
Larkin Behavioral Health Services
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Treese, MD
Phone
305-722-8444
Facility Name
Behavioral Clinical Research, Inc
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Lapeyra, MD
Phone
305-722-8444
Facility Name
Premier Clinical Research Institute, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emelina Arocha, MD
Phone
305-392-0279
Facility Name
Nova Psychiatry, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Medina, MD
Phone
407-718-3530
Facility Name
Advanced Discovery Research LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Purselle
Phone
470-777-8839
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Johnson, MD
Phone
404-881-5800
Facility Name
Atlanta Behavioral Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30358
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suneel Katragadda, MD
Phone
770-458-0447
Ext
op 3
Facility Name
Uptown Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Sonnenberg, PhD
Phone
773-989-8313
Ext
119
Facility Name
CBH Health
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elia Acevedo Diaz, MD
Phone
301-251-4702
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohd Malik, MD
Phone
314-849-1853
Ext
206
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cassie Blanchard
Phone
856-753-7335
Ext
722
Facility Name
New Hope Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurian Abraham, MD
Phone
980-209-9784
Facility Name
Clinical Trials of America, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Barker, MD
Phone
828-322-3222
Facility Name
Charak Clinical Research Center
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakesh Ranjan, MD
Phone
877-463-9633
Facility Name
Pillar Clinical Research, LLC
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Bartley, MD
Phone
214-396-4844

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study may be made available upon request via the Vivli Center for Global Clinical Research Data site.
IPD Sharing Time Frame
IPD will be made available upon request within 12 months of posting the study results on ct.gov.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
http://Vivli.org

Learn more about this trial

A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

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