Heart Rate Changes in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine (HeartAriQue)

January 11, 2010 updated by: Taichung Veterans General Hospital

Changes of Heart Rate Variability in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine

The goal of this research is investigating the heart rate changes in schizophrenic and bipolar patients under the medication of aripiprazole and quetiapine. In the mean time, we are hoping further investigating the interrelationship of medicine dosage and heart rate change, in order to acquire the best relationship both effectiveness as well as safety in acceptable heart rate change of clinical suggestion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary Goal: The goal of this research is investigating the heart rate changes in schizophrenic and bipolar patients under the medication of aripiprazole and quetiapine. As we known, clozapine, an antipsychotic, could cause fatal cardiac arrhythmia; in previous reports showed fatal rate about 0.7%, in spite of not very high, it reflects heart rate change decreasing. Therefore, many researches begin to focus on the relationship and heart rate change. Quetiapine, an atypical antipsychotic, FDA approved in 1997, Department of Health (DOH) in Taiwan also approved for schizophrenia for its effectiveness of negative disorders, low extrapyramidal syndrome, low side-effects of muscle catatonia and sluggishness. The side-effects of quetiapine are lethargy, nausea (occur rate 9%-44%), insomnia (12%), postural hypotension (4%-7%), constipation(8-10%), thirsty (9%-44%), weight gain (5-23%) and liver enzyme (GGT、AST、ALT) increasing (6%). Aripiprazole, FDA approved in 2002, DOH in Taiwan also approved for schizophrenia for its effective remittance of positive disorders, also effective for negative disorders and cognitive function regression. Besides, aripiprazole combine lithium or valproic acid can control the onset of manic and mixure of bipolar patients. The side-effects of aripiprazole are few, low extrapyramidal syndrome, no significant weight gain and blood sugar level, not surge in prolactin level and low menstrual cycle abnormal, gynecomastia and sexual dysfunction. Other side-effects are postural hypotension (0.6%-4%), headache (12%-27%), lethargy (8%-18%), insomnia (5%-26.3%), constipation (5-11%). Both quetiapine and aripiprazole are atypical antipsychotic, serious side-effects are fewer than typical antipsychotics, however, in some sensitive patients still have some side-effects such as limb-stiffness and akathisia (quetiapine 4%-12%, aripiprazole 2%-27.3%). In some retrospect researches, quetiapine will increase the opportunity of cardio- sudden death and pass off by 0.3%-1% in age 30-74 adult. On the other hand, aripiprazole (0.1%-1%) showed prolonging of QT wave which was considered as a danger factor of fatal arrhythmia. Despite of the danger, serious side-effects are rare, aripiprazole and quetiapine are widely used in clinical.

This study hope to further study whether quetiapine and aripiprazole will occur heart rate changes similar to clozapine, using heart rate changes approach to find out the possibility of causing arrhythmia and fatal of these 2 medicines.

Secondary goal:

  1. Further investigate the relationship of drug dosage and heart rate change, in order to acquire the best relationship both effectiveness as well as safety in acceptable heart rate change of clinical suggestion.
  2. The subjects of this study are schizophrenic and bipolar patients, who use quetiapine and aripiprazole, also will stratify into gender, age and influence of heart rate changes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung City, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 20 to 50, all genders.
  2. Psychiatry doctor diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and using antipsychotics.
  3. Psychiatry doctor first diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and without using antipsychotics.
  4. Participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. Participants need to understand the procedure of this study.
  5. Participants voluntarily join this interview, approximately 30-45min.
  6. Clinical reviewed patient's condition need to use quetiapine or aripiprazole.

Control group

  1. Age between 20 to 50, all genders.
  2. Psychiatry doctor diagnosed who exclude DSM-IV-TR schizophrenia or bipolar patients.
  3. Participants understand the goal of this experiment and willing to cooperate for evaluating heart rate change measurement. Participants need to understand the procedure of this study.
  4. Participants voluntarily join this interview, approximately 30-45min.

Exclusion Criteria:

Experimential Group:

  1. Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
  2. Participant has another major mental disease other than the inclusion criteria.
  3. Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
  4. Participant has combination diseases, it could seriously influence diagnosis.
  5. Psychopathy or psychosis can not be categorized in defined group.
  6. Clinical reviewed patient's condition need to switch other medicine.
  7. Clinical reviewed patient's condition need to quite this experiment and record reasons.
  8. Participants decide to quite experiment without any conditions.

Control group

  1. Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
  2. Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
  3. Participants decide to quite experiment without any conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Aripipazole
Heart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication
Drug: Aripiprazole; Quetiapine
Aripiprazole Quetiapine
Active Comparator: Quetiapine
Heart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication
Drug: Aripiprazole; Quetiapine
Aripiprazole Quetiapine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taichung Veterans General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Tsuo-Hung Lan, MD., PhD., Taichung Veterans General Hospital
  • Study Director: Tsuo-Hung Lan, MD.,PhD, Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C09032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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