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A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Aripiprazole Low (2 mg/day)
Aripiprazole Mid (6 - 12 mg/day)
Aripiprazole High (24 - 30 mg/day)
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 Schyzophrenia, 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 (M.I.N.I.KID will be used as backup)
  • Male and female patients aged 13-17 years (between IC and end of dosing)
  • Patients with a PANSS score of 70 or more [both at start of dosing (Day 1 and at baseline
  • 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 have a history of receiving treatment with clozapine, or who have received sufficient doses of two or more kinds of antipsychotic drug for more than four weeks but failed to respond to this treatment
  • Patients who have received a prohibited concomitant medication or therapy listed in table 6.4-1 after the start of the prohibited concomitant medication timeframe [to be confirmed at start of dosing (Day 1) and at baseline].
  • Patients who have a history of receiving treatment with aripiprazole
  • 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 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 and have a negative pregnancy test result are eligible for inclusion in this study.
  • Patients who have a diagnosis of a substance-related disorder according to DSM-Ⅳ-TR within the past 3 months
  • Patients with a positive drug screen (urine) result
  • Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low (2 mg/day)

Mid (6 - 12 mg/day)

High (24 - 30 mg/day)

Arm Description

Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).

Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.

Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.

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 Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score
The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition.
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 Clinical Global Impression-Improvement (CGI-I) Score
The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.
Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score
The Children's Global Assessment Scale (C-GAS) 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
NCT01942161
Brief Title
A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
Official Title
A Multicenter, Double-blind, Randomized, Dose-comparison Study of Three Different Doses of Aripiprazole (2 mg/Day, 6-12 mg/Day, 24-30 mg/Day) Orally Administered Over 6 Weeks in Pediatric Patients (Aged 13-17 Years) With Schizophrenia
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 2014 (Actual)
Study Completion Date
November 2014 (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 efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low (2 mg/day)
Arm Type
Experimental
Arm Description
Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Arm Title
Mid (6 - 12 mg/day)
Arm Type
Experimental
Arm Description
Subjects in the 6-12 mg/day group will be administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg in accordance with the criteria below.
Arm Title
High (24 - 30 mg/day)
Arm Type
Experimental
Arm Description
Subjects in the 24-30 mg/day group will be administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg in accordance with the criteria below.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole Low (2 mg/day)
Other Intervention Name(s)
Aripiprazole
Intervention Description
administered 2 mg once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Aripiprazole Mid (6 - 12 mg/day)
Other Intervention Name(s)
Aripiprazole
Intervention Description
administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg
Intervention Type
Drug
Intervention Name(s)
Aripiprazole High (24 - 30 mg/day)
Other Intervention Name(s)
Aripiprazole
Intervention Description
administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
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
Baseline (Day 1) and Day 43
Secondary Outcome Measure Information:
Title
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score
Description
The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition.
Time Frame
Baseline (Day 1) and Day 43
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
Baseline (Day 1) and Day43
Title
Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score
Description
The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.
Time Frame
Baseline (Day 1) and day43
Title
Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score
Description
The Children's Global Assessment Scale (C-GAS) 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 (Day 1) and Day 43

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 (M.I.N.I.KID will be used as backup) Male and female patients aged 13-17 years (between IC and end of dosing) Patients with a PANSS score of 70 or more [both at start of dosing (Day 1 and at baseline 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 have a history of receiving treatment with clozapine, or who have received sufficient doses of two or more kinds of antipsychotic drug for more than four weeks but failed to respond to this treatment Patients who have received a prohibited concomitant medication or therapy listed in table 6.4-1 after the start of the prohibited concomitant medication timeframe [to be confirmed at start of dosing (Day 1) and at baseline]. Patients who have a history of receiving treatment with aripiprazole 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 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 and have a negative pregnancy test result are eligible for inclusion in this study. Patients who have a diagnosis of a substance-related disorder according to DSM-Ⅳ-TR within the past 3 months Patients with a positive drug screen (urine) result 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 Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

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