Acute Psychosis Treatment in the Long Term, Unitary Group Study (APLUS)

December 15, 2009 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

Multicenter, Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder.

The purpose of this study is to prove safety and efficacy of aripiprazole.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed to prove safety and efficacy of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder in Korea and to confirm the maintenance of efficacy and safety during maintenance period and the changes in emotional factors and social functions.

After administering 15 mg/day of aripiprazole for two weeks, the test may change the dose within the range of 10 mg and 30 mg per day by clinical judgment. (Medication duration: 8 weeks (acute phase) + 18 weeks (maintenance phase)] + 26 weeks (extension phase), *total 52 weeks)

Study Type

Interventional

Enrollment

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Schizophrenia or schizoaffective disorder patients as defined by the DSM-IV criteria having an acute relapse
  2. 18 to 65 years
  3. Males and females (females of child bearing potential must use acceptable contraception and must not be pregnant and lactating; females of child-bearing potential must have negative serum pregnancy test)
  4. Randomization to this study must occur no more than four weeks following the day of initiation of treatment for the present episode/relapse.
  5. Should have a total PANSS score of at least 60. In addition, patients should have scores of at least 4 ("moderate") on any two of the four PANSS items that constitute the psychotic item subscale (hallucinatory behavior, delusions, conceptual disorganization, and suspiciousness).
  6. Patients must be able to be rated reliably on the battery of psychiatric and movement rating scales required by the protocol.
  7. Patients eligible to enter the study must sign an informed consent form.

Exclusion Criteria:

  1. Patients who are violent
  2. Patients who, in the opinion of the investigator, have serious suicidal ideation
  3. Patients who are liable to serious suicide attempt, by clinical judgment
  4. Patients who currently have a psychiatric diagnosis other than schizophrenia, schizophrenic form disorder or schizoaffective disorder requiring pharmacotherapy
  5. Patients who have any of the following neurologic diagnoses: migraine, epilepsy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, residual of stroke, transient cerebral ischemic attacks, "cerebral palsy" or any other condition that requires intermittent or maintenance treatment, or which is manifested by any abnormality on neurologic examination
  6. Patients who must continue to take, or who may potentially need to take, during this study, any of the following concomitant medication, which could cause unwanted drug-to-drug interactions or which could confound the analysis of antipsychotic effectiveness: Tegretol (carbamazepine), Depakene Depakote (valproic acid or sodium valproate or divalproate sodium), Lithium carbonate and lithium citrate
  7. Patients under treatment of schizophrenia : those who had taken antipsychotic drugs (consta) before randomization
  8. Patients who must continue to take, during this study, drugs or substances known as strong suppressive agents of microsomal enzyme CYP2D6
  9. Patients with any gastrointestinal resection, stomach stapling, or any other condition that may impair the absorption of the study medication
  10. Patients who currently meet the DSM-IV criteria for psychoactive substance dependence or patients with a history of substance or alcohol dependence (according to the DSM-IV criteria) within one month prior to the beginning of the study
  11. Patients having any somatic condition whose symptoms or physical signs could be misinterpreted as signs or symptoms of psychosis or as adverse effects from antipsychotic medications.
  12. Patients with any acute or unstable medical condition requiring pharmacotherapy
  13. Patients with any abnormal laboratory test result as judged by investigator
  14. Patients who have participated in any previous aripiprazole clinical study
  15. Patients having taken an investigational drug within the four weeks which precede the start of placebo washout

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PANSS-total score (at screening, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)

Secondary Outcome Measures

Outcome Measure
[Efficacy] PANSS-positive, PANSS-negative, CGI-severity score (at screening, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
[Safety] AEs (at baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
SAS, AIMS, Barnes (at baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
vital signs (at screening, baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
body weight (at screening, baseline, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
electrocardiogram (ECG) (at screening & week 8)
serum prolactin concentration (at screening & week 8)
routine laboratory test (at screening & week 8)
urinalysis (at screening & week 8)
Pharmacokinetic is evaluated by concentration of aripiprazole in blood (at Week 3, 4, 6, 8).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jun-Su Kwon, Prof., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 17, 2006

First Submitted That Met QC Criteria

March 17, 2006

First Posted (Estimate)

March 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 17, 2009

Last Update Submitted That Met QC Criteria

December 15, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOP-010401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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