Augmenting Clozapine With Sertindole - SERCLOZ

Schizophrenia Clinical Trial

Official title:

Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345982
• Other study ID #: 2005/150
• Status: Completed
• Phase: N/A
• First received: June 28, 2006
• Last updated: September 24, 2010
• Start date: September 2006
• Est. completion date: September 2010

Study information

• Verified date: September 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether addition of sertindole to clozapine treatment can improve psychosis or the metabolic side-effects of clozapine in patients with treatment-resistant schizophrenia.

Description:

Around 20 % of patients with schizophrenia are treatment-resistant. Clozapine is still the drug of choice for these patients but 2/3 will not respond adequately to clozapine. In the study clozapine treatment is augmented with sertindole. Patients are randomized to either clozapine or sertindole for 12 weeks and continue in a open-label study with sertindole for 12 weeks. The purpose of the open-label study is to determine whether clozapine dosage can be reduced due to the addition of sertindole.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ICD10 diagnosis of schizophrenia (F20.0-3)

• Clozapine treatment minimum 6 months

• Total PANSS >65

• No antipsychotic other than clozapine drug 1 month prior inclusion

Exclusion Criteria:

• QTc >500 ms

• Violence to SPC of clozapine or Serdolect

• Major depression

• Significant substance misuse interfering with participating in the study

• Cardiovascular disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Serdolect
16 mg, 12 weeks
• placebo
placebo

Locations

Country	Name	City	State
Denmark	Aalborg Psychiatric Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	H. Lundbeck A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS total score		12 weeks	No
Secondary	GAF		12 weeks	No
Secondary	WHOQOL-BREF		12 weeks	No
Secondary	CGI		12 weeks	No
Secondary	DAI		12 weeks	No
Secondary	Cognitive test		12 weeks	No
Secondary	Fasting glucose		12 weeks	No
Secondary	Lipids		12 weeks	No
Secondary	Hb1Ac		12 weeks	No