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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Korea Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective disorder, Aripiprazole

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Schizophrenia or schizoaffective disorder patients as defined by the DSM-IV criteria having an acute relapse 18 to 65 years 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) Randomization to this study must occur no more than four weeks following the day of initiation of treatment for the present episode/relapse. 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). Patients must be able to be rated reliably on the battery of psychiatric and movement rating scales required by the protocol. Patients eligible to enter the study must sign an informed consent form. Exclusion Criteria: Patients who are violent Patients who, in the opinion of the investigator, have serious suicidal ideation Patients who are liable to serious suicide attempt, by clinical judgment Patients who currently have a psychiatric diagnosis other than schizophrenia, schizophrenic form disorder or schizoaffective disorder requiring pharmacotherapy 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 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 Patients under treatment of schizophrenia : those who had taken antipsychotic drugs (consta) before randomization Patients who must continue to take, during this study, drugs or substances known as strong suppressive agents of microsomal enzyme CYP2D6 Patients with any gastrointestinal resection, stomach stapling, or any other condition that may impair the absorption of the study medication 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 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. Patients with any acute or unstable medical condition requiring pharmacotherapy Patients with any abnormal laboratory test result as judged by investigator Patients who have participated in any previous aripiprazole clinical study Patients having taken an investigational drug within the four weeks which precede the start of placebo washout

Sites / Locations

  • Seoul National University Hospital

Outcomes

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).

Full Information

First Posted
March 17, 2006
Last Updated
December 15, 2009
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00304655
Brief Title
Acute Psychosis Treatment in the Long Term, Unitary Group Study (APLUS)
Official Title
Multicenter, Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective disorder, Aripiprazole

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Schizophrenia or schizoaffective disorder patients as defined by the DSM-IV criteria having an acute relapse 18 to 65 years 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) Randomization to this study must occur no more than four weeks following the day of initiation of treatment for the present episode/relapse. 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). Patients must be able to be rated reliably on the battery of psychiatric and movement rating scales required by the protocol. Patients eligible to enter the study must sign an informed consent form. Exclusion Criteria: Patients who are violent Patients who, in the opinion of the investigator, have serious suicidal ideation Patients who are liable to serious suicide attempt, by clinical judgment Patients who currently have a psychiatric diagnosis other than schizophrenia, schizophrenic form disorder or schizoaffective disorder requiring pharmacotherapy 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 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 Patients under treatment of schizophrenia : those who had taken antipsychotic drugs (consta) before randomization Patients who must continue to take, during this study, drugs or substances known as strong suppressive agents of microsomal enzyme CYP2D6 Patients with any gastrointestinal resection, stomach stapling, or any other condition that may impair the absorption of the study medication 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 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. Patients with any acute or unstable medical condition requiring pharmacotherapy Patients with any abnormal laboratory test result as judged by investigator Patients who have participated in any previous aripiprazole clinical study Patients having taken an investigational drug within the four weeks which precede the start of placebo washout
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Su Kwon, Prof.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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