Clinical trial NCT05628103: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-28
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study 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.

Detailed description: This is an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.

Following a screening period of up to 21 days, eligible participants will take part in the study. In the 8-week treatment period, participants will be treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants will be required to complete the follow-up visit, 7 days after the last dose of SEP-363856.

Eligibility criteria: Inclusion Criteria: This list is not all inclusive

* Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
* Participants are 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.
* Participants 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.
* Participants are 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

* Participant 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.
* Participants are at significant risk of harming self or others based on investigator's judgment.
* Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
* Female participant who is pregnant or lactating.
* Participant tests positive for drugs of abuse at Screening.

Primary outcomes:
measure: Percentage of subjects who discontinue for clinical reasons (ie, discontinued due to an adverse event [AE] or lack of efficacy)
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percentage of subjects who discontinue for any reason (ie, all causes for discontinuation)
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Bellflower
country: United States
facility: Clinical Innovations Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Riverside
country: United States
facility: Clinical Innovations, Inc
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
state: California
city: Santee
country: United States
facility: CMB Clinical Trials
state: California
city: Torrance
country: United States
facility: Cenexel CNS Research
state: California
city: Hollywood
country: United States
facility: Larkin Behavioral Health Services
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Wellness Research Center
state: Florida
city: Orlando
country: United States
facility: Nova Psychiatry, Inc.
state: Florida
city: Atlanta
country: United States
facility: Advanced Discovery Research LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Behavioral Research
state: Georgia
city: Chicago
country: United States
facility: Uptown Research
state: Illinois
city: Gaithersburg
country: United States
facility: CBH Health
state: Maryland
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Las Vegas
country: United States
facility: IMA Clinical Research
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: Hickory
country: United States
facility: Clinical Trials of America, LLC
state: North Carolina
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: Richardson
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
Study officials:
References: