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Completed

NCT Number: NCT00345982

Augmenting Clozapine With Sertindole - SERCLOZ

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Psychiatric Hospital

Aalborg, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Serdolect

Drug

16 mg, 12 weeks

Other names: sertindole

Placebo

Drug

placebo

Primary outcomes

  1. PANSS total score

    Time frame: 12 weeks

Secondary outcomes

  1. GAF

    Time frame: 12 weeks

  2. WHOQOL-BREF

    Time frame: 12 weeks

  3. CGI

    Time frame: 12 weeks

  4. DAI

    Time frame: 12 weeks

  5. Cognitive test

    Time frame: 12 weeks

  6. Fasting glucose

    Time frame: 12 weeks

  7. Lipids

    Time frame: 12 weeks

  8. Hb1Ac

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2006
Registry last updated
Sep 27, 2010

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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