Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00763438
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Sertindole	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sertindole	Drug: Sertindole; Flexible dose

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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• Withdrawn before the end of the SCoP study, 99824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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FR002	Allonnes		France	72703

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT00763438
• Other Study ID Numbers: 12009A; 2007.002160-10; NCT00563550
• First Posted: Oct 1, 2008
• Last Update Posted: Nov 8, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by H. Lundbeck A/S: Schizophrenia; Sertindole; Safety study
• Additional relevant MeSH terms: Schizophrenia; Sertindole

Study Results

No Results Posted as of Nov 8, 2016