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

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00304655
First received: March 17, 2006
Last updated: December 15, 2009
Last verified: December 2009

March 17, 2006
December 15, 2009
July 2004
May 2006   (final data collection date for primary outcome measure)
PANSS-total score (at screening, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
  • PANSS-total,
  • PANSS-positive score,
  • CGI-severity score.
Complete list of historical versions of study NCT00304655 on ClinicalTrials.gov Archive Site
  • [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).
  • PANSS-negative score,
  • time-to-response,
  • time-to-discontinuation due to lack of clinical response and adverse events,
  • rate of discontinuation,
  • score of social functioning,
  • evaluation of emotion,
  • Adverse events(AEs),
  • Simpson-Angus Scale(SAS),
  • Abnormal Involuntary Movement Scale(AIMS),
  • Barnes-Akathisia Rating Scale,
  • vital signs, body weight,
  • electrocardiogram(ECG),
  • serum prolactin concentration,
  • routine laboratory test
Not Provided
Not Provided
 
Acute Psychosis Treatment in the Long Term, Unitary Group Study (APLUS)
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.

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)

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Aripiprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2007
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00304655
KOP-010401
Not Provided
Korea Otsuka Pharmaceutical Co.,Ltd.
Korea Otsuka Pharmaceutical Co.,Ltd.
Not Provided
Principal Investigator: Jun-Su Kwon, Prof. Seoul National University Hospital
Korea Otsuka Pharmaceutical Co.,Ltd.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP