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OpenTrials
Completed

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhua Christian Hospital, Changhua, Taiwan

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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

Aripiprazole

Drug

Primary outcomes

  1. Change from baseline in Clinical Global Impression-Severity (CGI-S) scale after 52 weeks treatment.

    Time frame: Throughout the study

Secondary outcomes

  1. Change from baseline in CGI-S scale at each visit during the first 39 weeks treatment.

    Time frame: Throughout the study

  2. 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.

  3. Change from baseline in total score on WHOQOL-BREF questionnaire at each visit during the treatment period.

    Time frame: Throughout the study.

  4. Change from baseline in total score on PANSS (optional) questionnaire at each visit during the treatment period.

    Time frame: throughout the study

  5. Change from baseline in total score on SFS (optional) questionnaire at 12 and 52 weeks treatment.

    Time frame: Throughout the study.

  6. Change from Visit 2 on POM questionnaire at each visit during the 12-week switching period.

    Time frame: Throughout the study.

  7. 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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