A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

• ClinicalTrials.gov Identifier: NCT01942161
• Recruitment Status: Completed
• First Posted: September 13, 2013
• Results First Posted: June 28, 2017
• Last Update Posted: June 28, 2017
• Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Aripiprazole Low (2 mg/day); Drug: Aripiprazole Mid (6 - 12 mg/day); Drug: Aripiprazole High (24 - 30 mg/day)	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: August 2010
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Low (2 mg/day); 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); administered 2 mg once daily for 6 weeks; Other Name: Aripiprazole
Experimental: 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.	Drug: 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; Other Name: Aripiprazole
Experimental: 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.	Drug: 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; Other Name: Aripiprazole

Outcome Measures

Primary Outcome Measures :

1. Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline (Day 1) and Day 43 ]
   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 :

1. Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score [ Time Frame: Baseline (Day 1) and Day 43 ]
   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.
2. Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Baseline (Day 1) and Day43 ]
   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.
3. Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score [ Time Frame: Baseline (Day 1) and day43 ]
   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.
4. Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score [ Time Frame: Baseline (Day 1) and Day 43 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Japan

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kansai Region, Japan

Kanto Region, Japan

Kyushu Region, Japan

Shikoku Region, Japan

Tohoku Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

• Study Director: Kyoji Imaoka, Mr; Otsuka Pharmaceutical Co., Ltd.

More Information

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01942161
• Other Study ID Numbers: 031-09-003; JapicCTI-101146 ( Other Identifier: JAPIC )
• First Posted: September 13, 2013
• Results First Posted: June 28, 2017
• Last Update Posted: June 28, 2017
• Last Verified: April 2017

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

Schyzophrenia, pediatric patients

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Aripiprazole; Antidepressive Agents; Psychotropic Drugs; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Dopamine Agonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists