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OpenTrials
Completed

NCT Number: NCT00436371

Amisulpride in Schizophrenic Acute Phase Patients

To collect the safety and response of using Amisulpride in acute schizophrenic patients

Completed

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

Exclusion criteria

  • Patients previously treated with amisulpride
  • Patients have comorbidity which may interfere with the treatment or follow-up
  • Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
  • Patients currently/ or recently (< 3 months) withdrawn from drug or alcohol abuse
  • Pregnant or lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Amisulpride

Drug

Oral tablets

Primary outcomes

  1. Adverse events

    Time frame: all across the study

Secondary outcomes

  1. Clinical Global Impressions

    Time frame: All accross the study

  2. Patient compliance

    Time frame: all across the study

  3. Percentage of patient completing treatment

    Time frame: all across the study

  4. Changes in body weight

    Time frame: At baseline and day 84

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

The Use of Amisulpride in Schizophrenic Acute Phase Patients.

Acronym: ASAP

Important dates

Study start
2005
Primary completion
2006
First posted
Feb 19, 2007
Registry last updated
Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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