SOLIACS: Solian Solution in the Acute Setting

Solian Solution to Treat Schizophrenic Patients During an Acute Episode

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245674

Enrollment

300

Registered

2005-10-28

Start date

2005-06-30

Completion date

Unknown

Last updated

2008-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

During this study the efficacy and safety profile will be evaluated of the use of amisulpride in the form of a solution in schizophrenic patients with an acute episode. The main purpose of the study is to observe the anti-psychotic effect of amisulpride as a solution during the first days of an acute episode of schizophrenia.

Interventions

DRUGamisulpride

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* schizophrenic in-patients with an acute episode * aged between 18 and 65 years * written informed consent

Exclusion criteria

* pregnancy and breast-feeding * breast cancer, prolactinoma, pheochromocytoma * hypersensitivity to amisulpride or one of the other excipients * contra-indications when using amisulpride as per the SmPC

Design outcomes

Primary

Measure	Time frame
*analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.	—

Secondary

Measure	Time frame
*analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026