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Augmenting Clozapine With Sertindole - SERCLOZ

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345982
First Posted: June 29, 2006
Last Update Posted: September 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Aarhus
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 ]

Secondary Outcome Measures:
  • GAF [ Time Frame: 12 weeks ]
  • WHOQOL-BREF [ Time Frame: 12 weeks ]
  • CGI [ Time Frame: 12 weeks ]
  • DAI [ Time Frame: 12 weeks ]
  • Cognitive test [ Time Frame: 12 weeks ]
  • Fasting glucose [ Time Frame: 12 weeks ]
  • Lipids [ Time Frame: 12 weeks ]
  • Hb1Ac [ Time Frame: 12 weeks ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 28, 2006
First Posted: June 29, 2006
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by University of Aarhus:
Schizophrenia
Treatment-resistant
sertindole
clozapine

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