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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304655
• Other study ID #: KOP-010401
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2006
• Last updated: December 15, 2009
• Start date: July 2004
• Est. completion date: October 2007

Study information

• Verified date: December 2009
• Source: Korea Otsuka Pharmaceutical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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