NCT05956600

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prior to enrollment, eligible patients and their treating psychiatrist will decide whether the goal is to evaluate amisulpride as an antipsychotic that is added to the current medication or as an alternative monotherapy. All study participants will receive amisulpride in oral form. For monotherapy patients, after primary and secondary endpoints are recorded, the study psychiatrist will begin a gradual cross-taper of the patient's current antipsychotic medication to amisulpride. The goal will be to have the patient on monotherapy by the one-month rating. The dose of amisulpride will vary depending on whether amisulpride will be used as an add-on therapy or monotherapy. The starting dose of amisulpride will be 50 mg/day and will be increased in 50 mg increments every 2-3 days until the optimal dose is reached, as determined by the treating psychiatrist, with a maximum dose of 1,200 mg/day.

Conditions

• Schizophrenia, Treatment-Resistant

Interventions

Type	Name	Description
DRUG	Amisulpride 50 MG	Amisulpride 50 mg titrated to dose range of 50 to 1200 mg

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2026-01-01
• First posted: 2023-07-21
• Last updated: 2024-06-24