SchizophreniaPhase 4HEALTHNCT00520650
Health Evaluation of Abilify Long-term Therapy
A Phase 4 study testing Aripiprazole in people with Schizophrenia and Schizoaffective Disorder, run by Taiwan Otsuka Pharm. Co., Ltd at 9 sites in Taiwan.
Trial summary
This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Aripiprazole
- How many people
- 245 participants
- Where
- 9 sitesTaiwan
- Study dates
- Aug 2006to Apr 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients between the ages of 18 to 65.
- Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
- Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.
Who cannot join
- Pregnant or breast feeding women or planning a pregnancy.
- Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
- A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
- Patient has clinically relevant organic, neurological, or cardiovascular diseases.
- Patient has a history of drug or alcohol abuse within the last 12 weeks.
- Acute psychosis, acute suicidal ideation, or any acute psychiatric condition that might require emergent intervention.
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- Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the study treatment.
- Having participated other investigational drug study and taken the investigation drug within one month prior to study entry.
- Depot neuroleptics should be discontinued at least 2 months prior to enrollment.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Changhua Christian Hospital
Changhua
National Taiwan University Hospital Yun-Lin Branch
Douliu
Cardinal Tien Hospital Hsin Chu Mercy Branch
Hsinchu
Buddhist Tzu Chi General Hospital
Hualien City
Wei Gong Memorial Hospital
Miaoli
Chung Shan Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Cathay General Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.
Read the detailed description
Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Aripiprazole
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
Measured: Throughout the study
Secondary outcomes (7)
Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.
Measured: Throughout the study
Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.
Measured: Throughout the study.
Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.
Measured: Throughout the study.
Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.
Measured: throughout the study
Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.
Measured: Throughout the study.
Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.
Measured: Throughout the study.
CGI-I scores after 12, 26, 39, and 52 weeks of treatment.
Measured: Throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startAug 2006
- Primary completionApr 2009
- Study completionApr 2009
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiwan Otsuka Pharm. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wei-Wen Lin, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520650
- Sponsor's protocol ID
- 31-06-P01
- Acronym
- HEALTH
- Status last verified
- Dec 2009
- First submitted
- 23 Aug 2007
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Evaluation of Abilify Long-term Therapy
- ClinicalTrials.gov ID
- NCT00520650
- Acronym / sponsor ID
- HEALTH / 31-06-P01
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Taiwan Otsuka Pharm. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 24 Aug 2007 (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.
This is a post-market surveillance, and the treatment to patients will be depended upon the decision based on physician's clinical judgment. The health profiles during the switching period, after 12 weeks short-term use, and after 52 weeks long-term use of aripiprazole will be recorded and evaluated.
Detailed description
Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients between the ages of 18 to 65.
- Having a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
- Who are currently taking antipsychotic drugs and clinically intolerable or inadequately controlled that is based upon the clinical judgment of the investigator.
Key exclusion criteria (9 listed)
- Pregnant or breast feeding women or planning a pregnancy.
- Patient received electroconvulsive therapy within 4 weeks before the Screening Visit.
- A known allergy reaction to any antipsychotic medication (including but not limited to haloperidol, chlorpromazine, thioridazine, pimozide, risperidone, quetiapine, ziprasidone).
- Patient has clinically relevant organic, neurological, or cardiovascular diseases.
- Patient has a history of drug or alcohol abuse within the last 12 weeks.
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 | Drug | – |
Primary outcome
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
Time frame: Throughout the study
7 secondary outcomes
Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.
Time frame: Throughout the study
Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.
Time frame: Throughout the study.
Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.
Time frame: Throughout the study.
Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.
Time frame: throughout the study
Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.
Time frame: Throughout the study.
Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.
Time frame: Throughout the study.
CGI-I scores after 12, 26, 39, and 52 weeks of treatment.
Time frame: Throughout the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
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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.
Wei-Wen Lin, MD principal investigator
Tri-Service General Hospital (TSGH)
9 sites 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 in people with Schizophrenia and Schizoaffective Disorder, run by Taiwan Otsuka Pharm. Co., Ltd at 9 sites 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 16 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment. (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
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 16 Dec 2009.