SchizophreniaPhase 4HeartAriQueNCT01047215
Heart Rate Changes in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine
A Phase 4 study testing Aripiprazole; Quetiapine in people with Schizophrenia and Bipolar, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar
- What is being tested?
- Aripiprazole; Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 to 50, all genders.
- Psychiatry doctor diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and using antipsychotics.
- Psychiatry doctor first diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and without using antipsychotics.
- 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.
- Participants voluntarily join this interview, approximately 30-45min.
- Clinical reviewed patient's condition need to use quetiapine or aripiprazole.
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- Control group
- Age between 20 to 50, all genders.
- Psychiatry doctor diagnosed who exclude DSM-IV-TR schizophrenia or bipolar patients.
- 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.
- Participants voluntarily join this interview, approximately 30-45min.
Who cannot join
- Experimential Group:
- Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
- Participant has another major mental disease other than the inclusion criteria.
- Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
- Participant has combination diseases, it could seriously influence diagnosis.
- Psychopathy or psychosis can not be categorized in defined group.
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- Clinical reviewed patient's condition need to switch other medicine.
- Clinical reviewed patient's condition need to quite this experiment and record reasons.
- Participants decide to quite experiment without any conditions.
- Control group
- Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
- Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
- Participants decide to quite experiment without any conditions.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Tsuo-Hung Lan, MD., PhD., 886-4-23592525 ext. 3460, tosafish@hotmail.com
Jui-Hung Lin, MD., 0966-381995, ryohoki.ryoko@gmail.com
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Schizophrenia, Bipolar
- Being tested
- Aripiprazole; Quetiapine
- Keywords
- schizophrenia, bipolar, aripiprazole, quetiapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole; QuetiapineDrug
Aripiprazole Quetiapine
| Study group | Role | What they receive |
|---|---|---|
| Aripipazole | Active comparator | Heart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication Receives: Drug: Aripiprazole; Quetiapine |
| Quetiapine | Active comparator | Heart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication Receives: Drug: Aripiprazole; Quetiapine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tsuo-Hung Lan, MD., PhD., Study director, Taichung Veterans General HospitalTsuo-Hung Lan, MD.,PhD, Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047215
- Sponsor's protocol ID
- C09032
- Acronym
- HeartAriQue
- Status last verified
- Jan 2010
- First submitted
- 6 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Heart Rate Variability in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine
- ClinicalTrials.gov ID
- NCT01047215
- Acronym / sponsor ID
- HeartAriQue / C09032
- Conditions
- Schizophrenia, Bipolar
- Keywords
- schizophrenia, bipolar, aripiprazole, quetiapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jun 2010 (estimated)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripipazole | Active comparator | Drug: Aripiprazole; QuetiapineHeart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication |
| Quetiapine | Active comparator | Drug: Aripiprazole; QuetiapineHeart rate change in schizophrenic and bipolar patients under the aripipazole and quetiapine medication |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age between 20 to 50, all genders.
- Psychiatry doctor diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and using antipsychotics.
- Psychiatry doctor first diagnosed who met DSM-IV-TR criteria schizophrenia or bipolar patients and without using antipsychotics.
- 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.
- Participants voluntarily join this interview, approximately 30-45min.
Key exclusion criteria (13 listed)
- Participants fail to understand the goal of this experiment and unwilling to cooperate for evaluating heart rate change measurement.
- Participant has another major mental disease other than the inclusion criteria.
- Participants have cardio-vascular disease, diabetes, hepatic cirrhosis, kidney disease, material abuser (smoking not excluded) and long-term-effective psychotics user.
- Participant has combination diseases, it could seriously influence diagnosis.
- Psychopathy or psychosis can not be categorized in defined group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aripiprazole; QuetiapineAripiprazole Quetiapine | Drug | Aripipazole, Quetiapine |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsuo-Hung Lan, MD., PhD. study director
Taichung Veterans General Hospital
Tsuo-Hung Lan, MD.,PhD study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aripiprazole; Quetiapine in people with Schizophrenia and Bipolar, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tsuo-Hung Lan, MD., PhD. (04-23592525 ext. 3460, tosafish@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.