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Augmenting Clozapine With Sertindole - SERCLOZ

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Serdolect
placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Treatment-resistant, sertindole, clozapine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Sertindole 16 mg

Placebo

Outcomes

Primary Outcome Measures

PANSS total score

Secondary Outcome Measures

GAF
WHOQOL-BREF
CGI
DAI
Cognitive test
Fasting glucose
Lipids
Hb1Ac

Full Information

First Posted
June 28, 2006
Last Updated
September 24, 2010
Sponsor
University of Aarhus
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00345982
Brief Title
Augmenting Clozapine With Sertindole - SERCLOZ
Official Title
Augmenting Clozapine With Sertindole - a Double Blinded Randomized Placebo Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Treatment-resistant, sertindole, clozapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Sertindole 16 mg
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Serdolect
Other Intervention Name(s)
sertindole
Intervention Description
16 mg, 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
PANSS total score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
GAF
Time Frame
12 weeks
Title
WHOQOL-BREF
Time Frame
12 weeks
Title
CGI
Time Frame
12 weeks
Title
DAI
Time Frame
12 weeks
Title
Cognitive test
Time Frame
12 weeks
Title
Fasting glucose
Time Frame
12 weeks
Title
Lipids
Time Frame
12 weeks
Title
Hb1Ac
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmi Nielsen, M.D.
Organizational Affiliation
Aalborg Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Psychiatric Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22367659
Citation
Nielsen J, Emborg C, Gydesen S, Dybbro J, Aagaard J, Haderup K, Glyngdal P, Fabricius S, Thode D, Lublin H, Andersen T, Damkier P, Taylor D. Augmenting clozapine with sertindole: a double-blind, randomized, placebo-controlled study. J Clin Psychopharmacol. 2012 Apr;32(2):173-8. doi: 10.1097/JCP.0b013e318248dfb8.
Results Reference
derived
PubMed Identifier
22356584
Citation
Nielsen RE, Levander S, Thode D, Nielsen J. Effects of sertindole on cognition in clozapine-treated schizophrenia patients. Acta Psychiatr Scand. 2012 Jul;126(1):31-9. doi: 10.1111/j.1600-0447.2012.01840.x. Epub 2012 Feb 22.
Results Reference
derived

Learn more about this trial

Augmenting Clozapine With Sertindole - SERCLOZ

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