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A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging | Clinical Trials | Clareo Health

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A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging

An Open-Label Positron Emission Tomography Study to Investigate the Effect of Adjunctive Administration of SEP-363856 on Brain Dopamine Synthesis Capacity Using 18F-DOPA in Adult Subjects With Schizophrenia

NCT04038957•Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

Summary

A clinical study to investigate the effect of an investigational drug as an added medication to an antipsychotic, in adults with schizophrenia, as measured positron emission tomography (PET) imaging . This study is accepting male and female participants between 18 years old -45 years old who have been diagnosed with schizophrenia. This study will be conducted in 2 locations in the UK. The study will last approximately 14 months.

Detailed Description

This is a single-site, open-label, flexibly-dosed study evaluating the effect on brain dopamine synthesis capacity as measured by 18F-DOPA PET imaging of adjunctive open-label administration of SEP-363856 (50 to 75 mg/day) over 2 weeks in adults with schizophrenia. The study will consist of 3 periods: Screening (up to 28 days), Treatment (2 weeks), and a Follow-up visit

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject must give written informed consent and privacy authorization prior to participation in the study.
•2\. Subject must be willing and able to comply with the study procedures and visit schedule, including required minimum week in-clinic treatment period, and must be able to understand and follow verbal and written instructions
•Male or female subject between 18 to 45 years of age (inclusive) at the time of consent
•Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-V Clinical Trials Version \[SCID-CT\]). The duration of the subject's illness whether treated or untreated must be ≥ 6 months.

Exclusion Criteria

•Subject must have a Clinical Global Impression-Severity (CGI-S) score ≥ 3 (mild or greater)
•Subject must have a Positive and Negative Syndrome Scale (PANSS) total score ≥ 70.
•. Subject's BMI must be at least 18 kg/m2 but no more than 35 kg/m2.
•Female subjects must have a negative serum pregnancy test at screening; as well as a negative urine pregnancy test prior to the PET scan on each day PET scans are performed, as well as prior to the MRI scan.
•1. Female subject of childbearing potential and male subject with female partner of childbearing potential must agree to use an acceptable form of birth control from at least 30 days prior to administration of the first dose of study drug, during the treatment period, and 60 days after completion or premature discontinuation from the study drug. Male subjects must also refrain from semen/sperm donation 30 days prior to administration of the first dose of study drug, during the treatment period, and 60 days after completion or premature discontinuation from the study drug.
•* 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 meroxyprogesterone 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. In the Investigator's judgment, the subject will adhere to this requirement.
•2. . Female subjects who are of non-childbearing potential are not required to abide by birth control requirements.
•\- Non-childbearing potential is defined as subject who is surgically sterile, has undergone tubal ligation, or is postmenopausal (defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with follicle stimulating hormone \[FSH\] concentrations within postmenopausal range as determined by laboratory analysis).
•Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, clinical laboratory values (hematology, serum chemistry urinalysis, lipid panel, coagulation panel, thyroid panel, and serum prolactin).
•Subject has had a stable living arrangement at the time of screening and agrees to return to a similar living arrangement after discharge. This criterion is not meant to exclude subjects who have temporarily left a stable living arrangement (eg, due to psychosis). Such subjects remain eligible to participate in this study. Chronically homeless subjects should not be enrolled.
+36 more criteria

Locations (1)

Research Site

London, United Kingdom

Key Dates

Start Date

August 7, 2019

Primary Completion Date

June 6, 2023

Completion Date

June 6, 2023

Last Updated

December 27, 2024

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

SEP-363856

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

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Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging

Inclusion Criteria

Exclusion Criteria

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