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An Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Amisulpride in Treating Patients With Schizophrenia and Schizoaffective Disorder Who Have Treatment-Resistant Positive Symptoms

NCT05956600 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-06-24

No results posted yet for this study

Summary

The objectives of this study are to evaluate the safety and efficacy of Amisulpride as an add-on therapy or alternative monotherapy in treating patients with schizophrenia or schizoaffective disorder who have treatment-resistant positive symptoms and who are not eligible for treatment with clozapine due to intolerance, failure from a prior clozapine trial, or unwillingness to be treated with clozapine.

Conditions

  • Schizophrenia, Treatment-Resistant

Interventions

DRUG

Amisulpride 50 MG

Amisulpride 50 mg titrated to dose range of 50 to 1200 mg

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2025-11-30
Completion
2026-01-31

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956600 on ClinicalTrials.gov