Augmenting Clozapine With Sertindole - SERCLOZ | NCT00345982

Studies
Augmenting Clozapine With Sertindole - SERCLOZ

NCT00345982

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Sep 27, 2010Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Schizophrenia

Interventions

Serdolect
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jun 28, 2006

First Submission Date that Met QC Criteria

Jun 28, 2006

First Posted Date

Jun 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2010

Last Update Posted Date

Sep 27, 2010Estimated

Name	Class
H. Lundbeck A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Sertindole 16 mg	Drug: Serdolect
B	Placebo Comparator	Placebo	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serdolect	Drug	16 mg, 12 weeks	A	sertindole

Measure	Description	Time Frame
PANSS total score		12 weeks

Measure	Description	Time Frame
GAF		12 weeks
WHOQOL-BREF		12 weeks
CGI		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jimmi Nielsen, M.D.	Aalborg Psychiatric Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg Psychiatric Hospital		Aalborg		9000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22367659	Derived	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.
22356584	Derived

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders