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CompletedNCT01942148Updated Jun 28, 2017Results posted

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

A Phase 3 interventional study of Aripiprazole in Schizophrenia, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 8 sites in Japan. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
13 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Schizophrenia

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Keywords

  • Schizophrenia, Pediatric patients
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's enrollment of 68 is close to the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Aripiprazole

    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

    Drug: Aripiprazole

Interventions

  • DrugAripiprazole

    Also known as: Abilify

06

What researchers measure

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.

    Time frame: Basline and Week52

Secondary outcomes

  1. 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.

    Time frame: Basline and Week52

  2. 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.

    Time frame: Baseline and Week52

07

Results

Posted Jun 28, 2017

Participant flow

Participant flow — Overall Study
MilestoneAripiprazole
Started68
Completed41
Not completed27
Withdrew: Adverse event4
Withdrew: Lack of efficacy2
Withdrew: Physician decision11
Withdrew: Protocol violation1
Withdrew: Withdrawal by subject8
Withdrew: Use of the prohibition medicine1

Outcome measures

PrimaryMean 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.

Time frame:
Basline and Week52
Reported as:
Mean · units on a scale
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score
units on a scaleAripiprazole
Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score-7.9 ± 28.2
SecondaryMean 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.

Time frame:
Basline and Week52
Reported as:
Mean · units on a scale
Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score
units on a scaleAripiprazole
Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score-0.3 ± 1.1
SecondaryMean 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.

Time frame:
Baseline and Week52
Reported as:
Mean · units on a scale
Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)
units on a scaleAripiprazole
Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)5.6 ± 19.8

Adverse events

Collected over From the start date of screening examination to date of the final examination. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Aripiprazole—7/68 (10.3%)61/68 (89.7%)
Most frequent serious events
Most frequent serious events
EventAripiprazole
SchizophreniaPsychiatric disorders5/68
Intentional overdoseInjury, poisoning and procedural complications1/68
Decreased appetiteMetabolism and nutrition disorders1/68
DelusionPsychiatric disorders1/68
HallucinationPsychiatric disorders1/68
Suicidal ideationPsychiatric disorders1/68
Most frequent other events
Showing 10 of 18
Most frequent other events
EventAripiprazole
NasopharyngitisInfections and infestations31/68
SomnolenceNervous system disorders14/68
NauseaGastrointestinal disorders12/68
VomitingGastrointestinal disorders11/68
HeadacheNervous system disorders9/68
AkathisiaNervous system disorders8/68
Weight increasedInvestigations8/68
TremorNervous system disorders6/68
SchizophreniaPsychiatric disorders6/68
Dental cariesGastrointestinal disorders5/68

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Aripiprazole
<=18 years68
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(years)Aripiprazole
Mean15.1 ± 1.4
Sex: Female, Male
Sex: Female, Male(Participants)Aripiprazole
Female31
Male37
Region of Enrollment
Region of Enrollment(participants)Aripiprazole
Japan68
08

Study locations

8 sites
  • Chubu Region, Japan
  • Chugoku Region, Japan
  • Hokkaido Region, Japan
  • Kansai Region, Japan
  • Kanto Region, Japan
  • Kyushu Region, Japan
  • Shikoku Region, Japan
  • Tohoku Region, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01942148
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 13, 2013
Start date
Aug 2010
Primary completion
Nov 2015
Completion
Nov 2015
Results posted
Jun 28, 2017
Last update
Jun 28, 2017

Study contacts

Kyoji Imaoka, Mr
study director · Otsuka Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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