NCT00178958

Brief Summary

The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2003

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

First QC Date

September 12, 2005

Last Update Submit

June 5, 2017

Conditions

SchizophreniaSchizoaffectiveBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • The aim of this study is to evaluate the utility of continuous Holter ECG recording with automated, computerized data analysis for measuring antipsychotic-related QTc prolongation during a 24-h period under clinical conditions.

Interventions

Holter MonitorDEVICE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be males or females between 18 - 65 years of age.
  • Patient subjects will have a definite diagnosis by DSM-IV criteria, schizophrenia, schizoaffective disorder, or bipolar disorder.
  • Patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months.
  • Patients have a history of taking the medications listed in item 3 as prescribed.
  • The subjects must be able to provide written informed consent

You may not qualify if:

  • Subjects with a DSM-IV diagnosis of substance dependence as defined by DSMN within three months prior to selection.
  • Subjects who are currently taking other medications that have been shown to prolong the QTc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

ElectrocardiographyHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Herbert Y Meltzer, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

August 1, 2003

Study Completion

June 1, 2006

Last Updated

June 7, 2017

Record last verified: 2017-06