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Augmenting Clozapine With Sertindole - SERCLOZ

This study has been completed.
H. Lundbeck A/S
Information provided by:
University of Aarhus Identifier:
First received: June 28, 2006
Last updated: September 24, 2010
Last verified: September 2010

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.

Condition Intervention
Drug: Serdolect
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • PANSS total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GAF [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • WHOQOL-BREF [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CGI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • DAI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Cognitive test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fasting glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Hb1Ac [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Sertindole 16 mg
Drug: Serdolect
16 mg, 12 weeks
Other Name: sertindole
Placebo Comparator: B
Drug: placebo
Other Name: placebo

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00345982

Aalborg Psychiatric Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
H. Lundbeck A/S
Principal Investigator: Jimmi Nielsen, M.D. Aalborg Psychiatric Hospital
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jimmi Nielsen, M.D, Aalborg Psychiatric Hospital Identifier: NCT00345982     History of Changes
Other Study ID Numbers: 2005/150
Study First Received: June 28, 2006
Last Updated: September 24, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2014