SchizophreniaPhase 3APEX 239NCT00102063

Aripiprazole in Adolescents With Schizophrenia

A Phase 3 study testing Aripiprazole tablet, 10 mg and Aripiprazole tablet, 30 mg in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 55 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks. 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 tablet, 10 mg and Aripiprazole tablet, 30 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 302 participants
Where: 55 sitesin 2 countries
Study dates: Jul 2004to Aug 2006
Phase: Phase 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

Primary diagnosis of Schizophrenia 1

Who cannot join

Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Trial locations and contacts

55 sites in 2 countries.

Country

City, postcode or hospital

55 sites in 2 countries

United States53 sites

Local Institution
Altamonte Springs, Florida
Local Institution
Bala-Cynwyd, Pennsylvania
Local Institution
Bellaire, Texas
Local Institution
Birmingham, Alabama
Local Institution
Chapel Hill, North Carolina
Local Institution
Chicago, Illinois
Local Institution
Cleveland, Ohio
Local Institution
Clinton Township, Michigan
Local Institution
Costa Mesa, California
Local Institution
DeSoto, Texas
Local Institution
Elmsford, New York
Local Institution
Flowood, Mississippi
Local Institution
Fort Lauderdale, Florida
Local Institution
Gainesville, Florida
Local Institution
Hialeah, Florida
Local Institution
Honolulu, Hawaii
Local Institution
Houston, Texas
Local Institution
Jacksonville, Florida
Local Institution
Kansas City, Kansas
Local Institution
Kansas City, Missouri
Local Institution
Kirkland, Washington
Local Institution
Lake Charles, Louisiana
Local Institution
Las Vegas, Nevada
Local Institution
Lexington, Kentucky
Local Institution
Little Rock, Arkansas
Local Institution
Los Angeles, California
Local Institution
Lyndhurst, Ohio
Local Institution
Medford, Massachusetts
Local Institution
Memphis, Tennessee
Local Institution
Miami, Florida
Local Institution
National City, California
Local Institution
New Orleans, Louisiana
Local Institution
New York, New York
Local Institution
Newnan, Georgia
Local Institution
North Miami, Florida
Local Institution
Oklahoma City, Oklahoma
Local Institution
Olean, New York
Local Institution
Orange, California
Local Institution
Orange City, Florida
Local Institution
Pasadena, California
Local Institution
Philadelphia, Pennsylvania
Local Institution
Richmond, Virginia
Local Institution
Rochester, New York
Local Institution
Sacramento, California
Local Institution
Salt Lake City, Utah
Local Institution
San Antonio, Texas
Local Institution
San Diego, California
Local Institution
Smyrna, Georgia
Local Institution
Spokane, Washington
Local Institution
Tampa, Florida
Local Institution
Temecula, California
Local Institution
Washington D.C., District of Columbia
Local Institution
Wauwatosa, Wisconsin

Other trials in United States

Puerto Rico2 sites

Local Institution
Rio Piedras
Local Institution
San Juan

Other trials in Puerto Rico

About this study

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Conditions: Schizophrenia
Being tested: Aripiprazole tablet, 10 mg, Aripiprazole tablet, 30 mg, Placebo tablet
Keywords: Schizophrenia, Aripiprazole
Medical subject headings: Schizophrenia

What participants receive

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

Aripiprazole tablet, 10 mgDrug
Also called OPC-14597
Aripiprazole tablet 10 mg po qd x 42 days
Aripiprazole tablet, 30 mgDrug
Also called OPC-14597
Aripiprazole tablet 30 mg po qd x 42 days
Placebo tabletDrug
Placebo tablet po qd x 42 days

Study groups in NCT00102063
Study group	Role	What they receive
Aripiprazole 10 mg/day Group	Active comparator	Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 Receives: Drug: Aripiprazole tablet, 10 mg
Aripiprazole 30 mg/day Group	Active comparator	Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25 Receives: Drug: Aripiprazole tablet, 30 mg
Placebo Group	Placebo comparator	Participants were given a single pill administered once daily Receives: Drug: Placebo tablet

What is being measured

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

Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward.
This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.
Measured: Baseline and Day 42

Secondary outcomes (5)

Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.
Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Measured: Baseline and Day 42
Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.
Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome.
Measured: Baseline and Day 42
Change in Clinical Global Impression (CGI) Severity Score
Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.
Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Measured: Baseline and Day 42
Clinical Global Impression (CGI) Improvement Score
Last observed post-baseline value in CGI improvement score, using the last observation carried forward.
Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe).
Measured: Baseline and Day 42
Change in Children's Global Assessment Scale (CGAS) Score
Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.
Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome).
Measured: Baseline and Day 42

Timeline

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

Jul 2004Aug 2006

First posted20 Jan 2005 (estimated)
Study startJul 2004
Primary completionAug 2006
Study completionAug 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00102063
Sponsor's protocol ID: 31-03-239
Acronym: APEX 239
Status last verified: Aug 2012
First submitted: 19 Jan 2005
Last updated: 10 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Correll CU, Zhao J, Carson W, Marcus R, McQuade R, Forbes RA, Mankoski R. Early antipsychotic response to aripiprazole in adolescents with schizophrenia: predictive value for clinical outcomes. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):689-698.e3. doi: 10.1016/j.jaac.2013.04.018. Epub 2013 Jun 5.
PubMed 23800482
Robb AS, Carson WH, Nyilas M, Ali M, Forbes RA, Iwamoto T, Assuncao-Talbott S, Whitehead R, Pikalov A. Changes in positive and negative syndrome scale-derived hostility factor in adolescents with schizophrenia treated with aripiprazole: post hoc analysis of randomized clinical trial data. J Child Adolesc Psychopharmacol. 2010 Feb;20(1):33-8. doi: 10.1089/cap.2008.0163.
PubMed 20166794
Findling RL, Robb A, Nyilas M, Forbes RA, Jin N, Ivanova S, Marcus R, McQuade RD, Iwamoto T, Carson WH. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. 2008 Nov;165(11):1432-41. doi: 10.1176/appi.ajp.2008.07061035. Epub 2008 Sep 2.
PubMed 18765484

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Severe Mental Illness, Inflammation
RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aripiprazole in Adolescents With Schizophrenia
ClinicalTrials.gov ID: NCT00102063
Acronym / sponsor ID: APEX 239 / 31-03-239
Conditions: Schizophrenia
Keywords: Schizophrenia, Aripiprazole
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2004
Primary completion: Aug 2006 (actual)
Study completion: Aug 2006 (actual)
First posted: 20 Jan 2005 (estimated)
Results: Posted 1 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Aripiprazole 10 mg/day Group	Active comparator	Drug: Aripiprazole tablet, 10 mgDose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
Aripiprazole 30 mg/day Group	Active comparator	Drug: Aripiprazole tablet, 30 mgDose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
Placebo Group	Placebo comparator	Drug: Placebo tabletParticipants were given a single pill administered once daily

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Primary diagnosis of Schizophrenia 1

Key exclusion criteria (1 listed)

Patients diagnosed with schizoaffective disorder, major depressive disorder, delirium, or bipolar disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aripiprazole tablet, 10 mgAlso: OPC-14597Aripiprazole tablet 10 mg po qd x 42 days	Drug	Aripiprazole 10 mg/day Group
Aripiprazole tablet, 30 mgAlso: OPC-14597Aripiprazole tablet 30 mg po qd x 42 days	Drug	Aripiprazole 30 mg/day Group
Placebo tabletPlacebo tablet po qd x 42 days	Drug	Placebo Group

Primary outcome

Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline and Day 42
Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward. This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome.

5 secondary outcomes

Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score
Time frame: Baseline and Day 42
Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score
Time frame: Baseline and Day 42
Change in Clinical Global Impression (CGI) Severity Score
Time frame: Baseline and Day 42
Clinical Global Impression (CGI) Improvement Score
Time frame: Baseline and Day 42
Change in Children's Global Assessment Scale (CGAS) Score
Time frame: Baseline and Day 42

Results and safety

Results posted to the registry on 1 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aripiprazole 10 mg/Day Group	100	84
Aripiprazole 30 mg/Day Group	102	84
Placebo Group	100	90

Primary outcome: Change in Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: Baseline and Day 42. Mean (Standard Error). Unit: points

Measure	Aripiprazole 10 mg/Day Group n = 99	Aripiprazole 30 mg/Day Group n = 97	Placebo Group n = 98
Value	-26.7 (1.9)	-28.6 (0.9)	-21.2 (1.9)

Aripiprazole 10 mg/Day Group vs Placebo Group: p = 0.05, t-test, 2 sided
Aripiprazole 30 mg/Day Group vs Placebo Group: p = 0.007, t-test, 2 sided

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected as spontaneous reports at all scheduled visits. Serious AEs were monitored until the subject's health returned to baseline status or other parameters returned to normal or were otherwise explained.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aripiprazole 10 mg/Day Group	4 of 100 (4%)	71 of 100 (71%)	Not reported
Aripiprazole 30 mg/Day Group	4 of 102 (3.9%)	74 of 102 (72.5%)	Not reported
Placebo Group	3 of 100 (3%)	57 of 100 (57%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23800482Correll CU, Zhao J, Carson W, Marcus R, McQuade R, Forbes RA, Mankoski R. Early antipsychotic response to aripiprazole in adolescents with schizophrenia: predictive value for clinical outcomes. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):689-698.e3. doi: 10.1016/j.jaac.2013.04.018. Epub 2013 Jun 5.
Derived from this study: PubMed 20166794Robb AS, Carson WH, Nyilas M, Ali M, Forbes RA, Iwamoto T, Assuncao-Talbott S, Whitehead R, Pikalov A. Changes in positive and negative syndrome scale-derived hostility factor in adolescents with schizophrenia treated with aripiprazole: post hoc analysis of randomized clinical trial data. J Child Adolesc Psychopharmacol. 2010 Feb;20(1):33-8. doi: 10.1089/cap.2008.0163.
Derived from this study: PubMed 18765484Findling RL, Robb A, Nyilas M, Forbes RA, Jin N, Ivanova S, Marcus R, McQuade RD, Iwamoto T, Carson WH. A multiple-center, randomized, double-blind, placebo-controlled study of oral aripiprazole for treatment of adolescents with schizophrenia. Am J Psychiatry. 2008 Nov;165(11):1432-41. doi: 10.1176/appi.ajp.2008.07061035. Epub 2008 Sep 2.

Related trials for Schizophrenia

Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Severe Mental Illness, Inflammation
RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Margaretta Nyilas, M.D. study director

Otsuka Pharmaceutical Development & Commercialization, Inc.

55 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 1 Aug 2012). 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?

Change in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline and Day 42). 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 NCT00102063, which also lists 3 linked publications.

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 10 Aug 2012.