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Augmenting Clozapine With Sertindole - SERCLOZ

Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Serdolect (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Jimmi Nielsen, M.D., Principal Investigator, Affiliation: Aalborg Psychiatric Hospital

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.

Clinical Details

Official title: Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study

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

Primary outcome: PANSS total score

Secondary outcome:

GAF

WHOQOL-BREF

CGI

DAI

Cognitive test

Fasting glucose

Lipids

Hb1Ac

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Aalborg Psychiatric Hospital, Aalborg 9000, Denmark
Additional Information

Starting date: September 2006
Last updated: September 24, 2010

Page last updated: August 20, 2015

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