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

Korea Otsuka Pharmaceutical Co., Ltd.1 site in 1 country300 target enrollmentJuly 2004

ConditionsSchizophrenia Schizoaffective Disorder

DrugsAripiprazole

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Enrollment: 300
Locations: 1
Primary Endpoint: PANSS-total score (at screening, week 1, 2, 3, 4, 6, 8, 12, 16, 26, 40, 52)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

October 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

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
•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

Outcomes

Primary Outcomes

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

Secondary Outcomes

[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)
Pharmacokinetic is evaluated by concentration of aripiprazole in blood (at Week 3, 4, 6, 8).
[Efficacy] PANSS-positive, PANSS-negative, CGI-severity score (at screening, 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)