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SchizophreniaPhase 2/3NCT01942161

A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

A Phase 2/3 study testing Aripiprazole Low (2 mg/day), Aripiprazole Mid (6 - 12 mg/day) and Aripiprazole High (24 - 30 mg/day) in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole Low (2 mg/day), Aripiprazole Mid (6 - 12 mg/day) and Aripiprazole High (24 - 30 mg/day)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
8 sitesJapan
Study dates
Aug 2010to Nov 2014
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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].
Show all 22Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Japan8 sites

  • Study site

    Chubu Region

  • Study site

    Chugoku Region

  • Study site

    Hokkaido Region

  • Study site

    Kansai Region

  • Study site

    Kanto Region

  • Study site

    Kyushu Region

  • Study site

    Shikoku Region

  • Study site

    Tohoku Region

Other trials in Japan

About this study

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

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
Being tested
Aripiprazole Low (2 mg/day), Aripiprazole Mid (6 - 12 mg/day), Aripiprazole High (24 - 30 mg/day)
Keywords
Schyzophrenia, pediatric patients
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole Low (2 mg/day)Drug

    Also called Aripiprazole

    administered 2 mg once daily for 6 weeks

  • Aripiprazole Mid (6 - 12 mg/day)Drug

    Also called Aripiprazole

    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

  • Aripiprazole High (24 - 30 mg/day)Drug

    Also called Aripiprazole

    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

Study groups in NCT01942161
Study groupRoleWhat they receive
Low (2 mg/day)ExperimentalSubjects in the 2 mg/day group will be administered 2 mg once daily for 6 weeks (42 days).
Receives: Drug: Aripiprazole Low (2 mg/day)
Mid (6 - 12 mg/day)ExperimentalSubjects 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.
Receives: Drug: Aripiprazole Mid (6 - 12 mg/day)
High (24 - 30 mg/day)ExperimentalSubjects 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.
Receives: Drug: Aripiprazole High (24 - 30 mg/day)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 1) and Day 43

Secondary outcomes (4)

  1. 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.

    Measured: Baseline (Day 1) and Day 43

  2. 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.

    Measured: Baseline (Day 1) and Day43

  3. 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.

    Measured: Baseline (Day 1) and day43

  4. 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.

    Measured: Baseline (Day 1) and Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2013 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01942161
Sponsor's protocol ID
031-09-003
Other IDs
JapicCTI-101146
Status last verified
Apr 2017
First submitted
10 Sep 2013
Last updated
28 Jun 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Aripiprazole Low (2 mg/day), Aripiprazole Mid (6 - 12 mg/day) and Aripiprazole High (24 - 30 mg/day) in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 8 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline (Day 1) and Day 43). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.

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