A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

NCT01942161 | Completed Phase 2 Results

• 2 other identifiers: 031-09-003JapicCTI-101146
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 8

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

Conditions

Schizophrenia

Keywords

Schyzophrenia, pediatric patients

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score

  Baseline (Day 1) and Day 43

• Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score

  Baseline (Day 1) and Day43

• Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score

  Baseline (Day 1) and day43

• Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score

  Baseline (Day 1) and Day 43

Study Arms (3)

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)

Interventions

Aripiprazole Low (2 mg/day) DRUG

administered 2 mg once daily for 6 weeks

Also known as: Aripiprazole

Low (2 mg/day)

Aripiprazole Mid (6 - 12 mg/day) DRUG

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

Also known as: Aripiprazole

Mid (6 - 12 mg/day)

Aripiprazole High (24 - 30 mg/day) DRUG

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

Also known as: Aripiprazole

High (24 - 30 mg/day)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (8)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Chugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shikoku Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd

+81-3-6361-7366

Study Officials

• Kyoji Imaoka, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 13, 2013
• Study Start: August 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-04

Locations

JP (8)