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A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Pediatric patients

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR
  • Male and female patients aged 13-17 years
  • Patients completing the 031-09-003 study
  • Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
  • Inpatient or outpatient status

Exclusion Criteria:

  • Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
  • Patients who have been compulsorily admitted to hospital
  • Patients with mental retardation
  • Patients with thyroid disorder
  • Patients who fall under a contraindication listed in the ABILIFY package insert
  • Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
  • Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
  • Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5%
  • Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
  • Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
  • Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
  • Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
  • Patients with a history or a complication of water intoxication
  • Patients with Parkinson's disease
  • Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study.
  • Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aripiprazole

Arm Description

Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study

Outcomes

Primary Outcome Measures

Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.

Secondary Outcome Measures

Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.

Full Information

First Posted
September 10, 2013
Last Updated
April 11, 2017
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01942148
Brief Title
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Official Title
A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Pediatric patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aripiprazole
Arm Type
Experimental
Arm Description
Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Other Intervention Name(s)
Abilify
Primary Outcome Measure Information:
Title
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.
Time Frame
Basline and Week52
Secondary Outcome Measure Information:
Title
Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
Description
The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.
Time Frame
Basline and Week52
Title
Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
Description
The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.
Time Frame
Baseline and Week52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR Male and female patients aged 13-17 years Patients completing the 031-09-003 study Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study Inpatient or outpatient status Exclusion Criteria: Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR Patients who have been compulsorily admitted to hospital Patients with mental retardation Patients with thyroid disorder Patients who fall under a contraindication listed in the ABILIFY package insert Patients with a serious hepatic, renal, cardiac or hematopoietic disorder Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5% Patients with a history or a complication of suicide attempt, suicidal thought or self-harm Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition Patients with a history or a complication of water intoxication Patients with Parkinson's disease Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study. Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoji Imaoka, Mr
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kansai Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan

12. IPD Sharing Statement

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A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

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