Safety, Tolerability, and Pharmacokinetics of Switching From Oral Risperidone to Risperidone Implant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Schizophrenia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety, tolerability, and PK of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period.
Phase 1 open-label study in stable schizophrenia patients designed to evaluate the safety, tolerability, and PK of switching from 2 mg/day or 3 mg/day oral risperidone to two DLP-114 devices for a six or twelve-month dosing period.
Tracking Information
- NCT #
- NCT04418466
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Not Provided
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