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Augmenting Clozapine With Sertindole - SERCLOZ

This study has been completed.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00345982
First received: June 28, 2006
Last updated: September 24, 2010
Last verified: September 2010
History of Changes
  Purpose

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
Schizophrenia
 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:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine
U.S. FDA Resources

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
Placebo
 Drug: placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00345982

Locations
Denmark
Aalborg Psychiatric Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
H. Lundbeck A/S
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jimmi Nielsen, M.D, Aalborg Psychiatric Hospital
ClinicalTrials.gov 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:
Schizophrenia
Treatment-resistant
sertindole
clozapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Sertindole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents

ClinicalTrials.gov processed this record on May 19, 2013