NCT Number: NCT00520650
Health Evaluation of Abilify Long-term Therapy
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.
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Changhua Christian Hospital, Changhua, Taiwan
About this study
Further study details as provided by Taiwan Otsuka Pharmaceutical Co., Ltd.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Treatment and study plan
Primary outcomes
-
Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.
Time frame: Throughout the study
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.
Sponsors and collaborators
Lead sponsor
Taiwan Otsuka Pharm. Co., Ltd
Industry
Registry information
Acronym: HEALTH
Important dates
- Study start
- 2006
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Aug 24, 2007
- Registry last updated
- Dec 16, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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