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CompletedNCT00245674Updated Apr 10, 2008

SOLIACS: Solian Solution in the Acute Setting

A Phase 4 interventional study of amisulpride in Schizophrenia, sponsored by Sanofi. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-04-10.

Sponsored by Sanofi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 300 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

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Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants

Interventions

  • Drugamisulpride
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What researchers measure

Primary outcomes

  1. *analyze the antipsychotic efficacy of amisulpride solution in the first days of an acute schizophrenic episode.

Secondary outcomes

  1. *analyse the safety profile of amisulpride solution in treatment of schizophrenics with an an acute episode.

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Study locations

1 site
  • Sanofi-aventis
    Diegem, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00245674
Lead sponsor
Sanofi
First posted
Oct 28, 2005
Start date
Jun 2005
Last update
Apr 10, 2008

Study contacts

Dr. Christian Fassotte, M.D.
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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