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Lipid and Cognitive Change with Paliperidone Palmitate 1M vs 3M in Schizophrenia
NCT04754750Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2015
- Primary completion
- Jun 2017
- Sponsor
- Calo Psychiatric Center
- Modality
- Metabolically Activated Prodrugs
- Conditions
- schizophrenia
01
Overview
Phase 2, open-label, single-arm trial of paliperidone palmitate in schizophrenia, sponsored by Calo Psychiatric Center. Primary endpoints: Personal and Social Performance Scale at 15 months, Udvalg for Kliniske Undersogelser Side Effect Rating Scale at 15 months and 1 more. Started Jan 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
PP1M to PP3M Sequence
Patients switch from Risperidone LAI to PP1M for 3 months, then to PP3M for 12 months.
03
Endpoints
Primary
Personal and Social Performance Scale
Udvalg for Kliniske Undersogelser Side Effect Rating Scale
Wisconsin Card Sorting Test
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