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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Aripiprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder.

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

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

Secondary Outcome Measures:
  • [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).

Estimated Enrollment: 300
Study Start Date: July 2004
Study Completion Date: October 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00304655

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: Jun-Su Kwon, Prof. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00304655     History of Changes
Other Study ID Numbers: KOP-010401
Study First Received: March 17, 2006
Last Updated: December 15, 2009
Health Authority: Korea: Institutional Review Board

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Schizophrenia
Schizoaffective disorder
Aripiprazole

Additional relevant MeSH terms:
Schizophrenia
Disease
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Pathologic Processes
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 01, 2014