A Short Treatment Study of Aripiprazole in Pediatric Pati... | NCT01942161

NCT01942161

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
JapicCTI-101146	Other Identifier	JAPIC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low (2 mg/day)	Experimental	Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).	Drug: Aripiprazole Low (2 mg/day)
Mid (6 - 12 mg/day)	Experimental	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.	Drug: Aripiprazole Mid (6 - 12 mg/day)
High (24 - 30 mg/day)	Experimental	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.	Drug: Aripiprazole High (24 - 30 mg/day)

Name	Type	Description	Arm Group Labels	Other Names
Aripiprazole Low (2 mg/day)	Drug	administered 2 mg once daily for 6 weeks	Low (2 mg/day)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline (Day 1) and Day 43

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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](streamdown:incomplete-link)

Name	Affiliation	Role
Kyoji Imaoka, Mr	Otsuka Pharmaceutical Co., Ltd.	Study Director

Arm/Group Information

ID	Title	Description
FG000	Low (2 mg/Day)	Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks
FG001	Mid (6 - 12 mg/Day)	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. Aripiprazole Mid (6 - 12 mg/day): 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
FG002	High (24 - 30 mg/Day)	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. Aripiprazole High (24 - 30 mg/day): 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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Low (2 mg/Day)	Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks
BG001	Mid (6 - 12 mg/Day)

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Day 43

ID	Title	Description
OG000	Low (2 mg/Day)	Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks
OG001	Mid (6 - 12 mg/Day)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low (2 mg/Day)	Subjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days). Aripiprazole Low (2 mg/day): administered 2 mg once daily for 6 weeks

Facility	Status	City	State	ZIP	Country	Contacts
		Chubu Region			Japan

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015363	Quinolones