NCT00520650

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 16, 2009

Status Verified

December 1, 2009

Enrollment Period

2.7 years

First QC Date

August 23, 2007

Last Update Submit

December 15, 2009

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

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

    Throughout the study

Secondary Outcomes (7)

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

    Throughout the study

  • Change from baseline in total score on the Brief Psychiatric Rating Scale (BPRS) at each visit during the treatment period.

    Throughout the study.

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

    Throughout the study.

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

    throughout the study

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

    Throughout the study.

  • +2 more secondary outcomes

Interventions

AripiprazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Changhua Christian Hospital

Changhua, Taiwan

Location

National Taiwan University Hospital Yun-Lin Branch

Douliu, Taiwan

Location

Cardinal Tien Hospital Hsin Chu Mercy Branch

Hsinchu, Taiwan

Location

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan

Location

Wei Gong Memorial Hospital

Miaoli, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Cathay General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Wei-Wen Lin, MD

    Tri-Service General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

August 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 16, 2009

Record last verified: 2009-12

Locations

TW(9)