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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT01047215
First received: January 6, 2010
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Bipolar
Drug: Aripiprazole; Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Changes of Heart Rate Variability in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047215

Contacts
Contact: Tsuo-Hung Lan, MD., PhD. 04-23592525 ext 3460 tosafish@hotmail.com
Contact: Jui-Hung Lin, MD. 0966381995 ryohoki.ryoko@gmail.com

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung City, Taiwan, 40705
Contact: Tsuo-Hung Lan, MD., PhD.    886-4-23592525 ext 3460    tosafish@hotmail.com   
Contact: Jui-Hung Lin, MD.    0966-381995    ryohoki.ryoko@gmail.com   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: IRB TCVGH, Taichung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01047215     History of Changes
Other Study ID Numbers: C09032
Study First Received: January 6, 2010
Last Updated: January 11, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taichung Veterans General Hospital:
schizophrenia
bipolar
aripiprazole
quetiapine

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014