EUCTR2019-000063-24-BG
Active, not recruiting
Phase 1
A Study to Evaluate the Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients with Schizophrenia - The SHINE Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 340
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Roll over patients:
- •The patient must have participated in the pivotal efficacy study (Study TV46000\-CNS\-30072\) without experiencing relapse events and without important protocol deviations.
- •New Patients:
- •The patient has a diagnosis of schizophrenia according to the DSM\-5 for \>1 year (diagnosis must be reconfirmed by SCID\-5\) and \=1 episode of relapse in the last 24 months.
- •please refer to the protocol for additional inclusion criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 300
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Roll Over and New patients:
- •The patient has a current clinically significant DSM\-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, or amnestic or other cognitive disorders, or borderline,
- •paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- •please refer to the protocol for additional exclusion criteria.
Outcomes
Primary Outcomes
Not specified
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