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Completed

NCT Number: NCT00763438

Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

FR002

Allonnes, 72703, France

About this study

Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participation in the previous SCoP study, 99824
  • Still fulfils the EU SPC requirements for Sertindole

Exclusion criteria

  • Withdrawn before the end of the SCoP study, 99824
  • Become homeless
  • Participation in another clinical trial at the same time
  • Unlikely to comply with the clinical study protocol or is unsuitable for any reason

Treatment and study plan

Sertindole

Drug

Flexible dose

Primary outcomes

  1. All serious adverse events reported; visits scheduled every 3 months

    Time frame: Every 3 months

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

A Prospective, Open-label, Single-arm, Multinational, Multi-centre, Flexible-dose, Extension Study of the SCoP 99824 With Sertindole for Patients Suffering From Schizophrenia

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 1, 2008
Registry last updated
Nov 8, 2016

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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