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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • 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 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

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
Intervention / Treatment
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

Taichung Veterans General Hospital

Investigators

  • 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

August 1, 2009

Primary Completion (Actual)

August 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

January 6, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 12, 2010

Last Update Submitted That Met QC Criteria

January 11, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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