Augmenting Clozapine With Sertindole - SERCLOZ

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT00345982
Collaborator
H. Lundbeck A/S (Industry)
50
1
2
48
1

Study Details

Study Description

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
N/A

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 Design

Study Type:
Interventional
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 :
Sep 1, 2006
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Sertindole 16 mg

Drug: Serdolect
16 mg, 12 weeks
Other Names:
  • sertindole
  • Placebo Comparator: B

    Placebo

    Drug: placebo
    placebo

    Outcome Measures

    Primary Outcome Measures

    1. PANSS total score [12 weeks]

    Secondary Outcome Measures

    1. GAF [12 weeks]

    2. WHOQOL-BREF [12 weeks]

    3. CGI [12 weeks]

    4. DAI [12 weeks]

    5. Cognitive test [12 weeks]

    6. Fasting glucose [12 weeks]

    7. Lipids [12 weeks]

    8. Hb1Ac [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00345982
    Other Study ID Numbers:
    • 2005/150
    First Posted:
    Jun 29, 2006
    Last Update Posted:
    Sep 27, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 27, 2010