Augmenting Clozapine With Sertindole - SERCLOZ

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. Identifier: NCT00345982
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : September 27, 2010
H. Lundbeck A/S
Information provided by:
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Serdolect Drug: placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Clozapine

Arm Intervention/treatment
Experimental: A
Sertindole 16 mg
Drug: Serdolect
16 mg, 12 weeks
Other Name: sertindole

Placebo Comparator: B
Drug: placebo

Primary Outcome Measures :
  1. PANSS total score [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): 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

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
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by University of Aarhus:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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