Serum Clozapine and Cognition | NCT00951418

Studies
Serum Clozapine and Cognition

NCT00951418

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Sep 12, 2013Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

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

Aug 2013

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

Jun 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Sep 2013Actual

First Submitted Date

Aug 3, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 2009Estimated

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 11, 2013

Last Update Posted Date

Sep 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive function measured by CANTAB		once

Secondary Outcomes

Measure	Description	Time Frame
T-wave morphology		Once
Sedation VAS,ACES and SWAI scale		once

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treated with clozapine for minimum 6 months.
Fixed dosage of clozapine last month before inclusion.

Exclusion Criteria:

Substance misuse.
Depression (Calgary Depression score ≥7).
Somatic disease that interfere with cognitive performance.
Treatment with benzodiazepines (half-lives >15 hours not allowed up 14 days prior inclusion and during study. Half-lives < 15 hours not allowed 3 days prior cognitive testing).
Electroconvulsive therapy.
Treatment with other antipsychotics.
Withdrawal of informed consent.
Compulsory measures.
Treatment with anticholinergics except for atropine drops administered sublingually.
Changes in use of tobacco last month before inclusion.

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

ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided