SOLIAN solution in the acute setting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004461-15-BE

Enrollment

500

Registered

2005-07-28

Start date

2005-04-05

Completion date

Unknown

Last updated

2014-03-24

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

Conditions

Acute schizophrenia episode MedDRA version: 7.0 Level: PT Classification code 10039626

Interventions

Trade Name: SOLIAN oral solution Product Name: SOLIAN oral solution Pharmaceutical Form: Oral solution INN or Proposed INN: amisulpride Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - schizophrenia - acute episode - age: 18-65 years - inpatients - written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - pregnant and lactating womens - breastcancer, prolactinoma, pheochromocytoma - hypersensitivity to amisulprideor any of the excipients - contraindications to the use of amisulpride according to the SmPC.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to analyze the antipsychotic efficacy of amisulpride oral solution in the first days of an acute schizophrenic episode.;Secondary Objective: This study will evaluate the early efficacy and safety of the use of amisulpride in a solution form in schizophrenic patients with an acute episode. ;Primary end point(s): CGI scale and PANSS positive scale.	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026