Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

NCT00538122 | Completed

• 1 other identifier: 070591
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to look at the electrical activity of the heart. This study will help decide whether taking recordings for a 24-hour period gives more useful information than recording it for a few seconds in a doctor's office. The study will compare 24 hour electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other patients taking different medications that took part in another study.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

schizophrenia; schizoaffective disorder; bipolar disorder; antipsychotic drug treatment; safety; arrythmias

Study Arms (1)

Thioridazine Group

Patients must have been treated with (Mellaril) thioridazine at least three months at time of enrollment.

Device: 24 Holter Monitor Recording

Interventions

24 Holter Monitor Recording DEVICE

All subjects will be fitted with a device to obtain 24-hour Holter EKG continuous recordings of bipolar leads C5C5R. They will also receive a standard 12-lead EKG recording prior to the placement of the Holter device. The subjects will be asked to keep a diary during the course of the 24 hours to record information such as wake and sleep times and symptoms such as shortness of breath, heart palpitations, lightheadedness, etc. From each recording, 12 sets of 10 consecutive QRS epochs, plus QRS samplings obtained during sleep will be analyzed by a cardiologist blind to the medication status of subjects.

Thioridazine Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed wtih schizophrenia, bipolar or schizoaffective disorder

You may qualify if:

• Patients must be male or female, age 18-65
• Patients must have a definitive diagnosis by DSM-IV criteria of schizophrenia, bipolar or schizoaffective disorder.
• Patients can be receiving inpatient or outpatient treatment at time of enrollment.
• Patients must have been treated with (Mellaril) thioridazine, (Risperdal) risperidone or (Seroquel) quetiapine at least three months at time of enrollment.
• Patients must be able to provide written informed consent

You may not qualify if:

• Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder
• Patients who are currently taking other medications that have been shown to prolong the QTC, including tricyclic antidepressants, fluoroquinolones or antiarrythmics.
• Patients unable to provide written informed consent.

Sponsors & Collaborators

• Vanderbilt University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Vanderbilt Psychiatric Hospital

Nashville, Tennessee, 37212-8645, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Herbert Meltzer, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: September 1, 2008
• Last Updated: January 27, 2009

Record last verified: 2009-01

Locations

US (1)