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Augmenting Clozapine With Sertindole - SERCLOZ

NCT ID: NCT00345982

Last Updated: 2010-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Sertindole 16 mg

Group Type EXPERIMENTAL

Serdolect

Intervention Type DRUG

16 mg, 12 weeks

B

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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Serdolect

16 mg, 12 weeks

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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sertindole

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Aalborg Psychiatric Hospital

Principal Investigators

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Jimmi Nielsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Aalborg Psychiatric Hospital

Locations

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Aalborg Psychiatric Hospital

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 22367659 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22356584 (View on PubMed)

Other Identifiers

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2005/150

Identifier Type: -

Identifier Source: org_study_id