SchizophreniaPhase 3APEX 241NCT00102518

Aripiprazole Open-Label, Safety and Tolerability Study

A Phase 3 study testing Aripiprazole in people with Schizophrenia and Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 50 sites in United States.

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 study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar I disorder, manic or mixed episode. Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Schizophrenia, Bipolar Disorder
What is being tested?: Aripiprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 325 participants
Where: 50 sitesUnited States
Study dates: Sep 2004to Feb 2007
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 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Who cannot join

Patients with a co-morbid serious, uncontrolled systemic illness
Patients with a significant risk of committing suicide

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

United States50 sites

Local Institution
Altamonte Springs, Florida
Local Institution
Atlanta, Georgia
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, Michigan
Local Institution
Costa Mesa, California
Local Institution
DeSoto, Texas
Local Institution
Elmsford, New York
Local Institution
Fort Lauderdale, Florida
Local Institution
Fresno, California
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
Lexington, Kentucky
Local Institution
Little Rock, Arkansas
Local Institution
Louisville, Kentucky
Local Institution
Lyndhurst, Ohio
Local Institution
Memphis, Tennessee
Local Institution
Metairie, Louisiana
Local Institution
Miami, Florida
Local Institution
New Orleans, Louisiana
Local Institution
New York, New York
Local Institution
Oklahoma City, Oklahoma
Local Institution
Olean, New York
Local Institution
Orange, California
Local Institution
Orange City, Florida
Local Institution
Philadelphia, Pennsylvania
Local Institution
Riverside, California
Local Institution
Rochester, New York
Local Institution
Rosemead, California
Local Institution
Sacramento, California
Local Institution
Saint Charles, Missouri
Local Institution
Salt Lake City, Utah
Local Institution
San Antonio, Texas
Local Institution
Seattle, Washington
Local Institution
Somerville, Massachusetts
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

About this study

Official title: A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Conditions: Schizophrenia, Bipolar Disorder
Being tested: Aripiprazole
Keywords: Open Label, Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode
Medical subject headings: Schizophrenia, Bipolar Disorder, Mania

What participants receive

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

AripiprazoleDrug
Also called OPC-14597
2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses

Study groups in NCT00102518
Study group	Role	What they receive
NCT00102063 and NCT00110461 Subjects	Experimental	All subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239). Receives: Drug: Aripiprazole

What is being measured

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

Percentage of Subjects Experiencing SAEs
Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.
Measured: Baseline and Week 23

Secondary outcomes (2)

Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).
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 Week 26
Change in Young Mania Rating Scale (Y-MRS) Total Score
Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).
The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms).
Measured: Baseline and Week 26

Timeline

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

Sep 2004Feb 2007

First posted31 Jan 2005 (estimated)
Study startSep 2004
Primary completionFeb 2007
Study completionFeb 2007

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 325 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00102518
Sponsor's protocol ID: 31-03-241
Acronym: APEX 241
Status last verified: Jul 2012
First submitted: 29 Jan 2005
Last updated: 31 Aug 2012
Results posted: Yes, on ClinicalTrials.gov

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
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Schizophrenia

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-Label, Safety and Tolerability Study of Flexible-Dose Oral Aripiprazole (2 Mg-30 mg) in the Treatment of Adolescent Patients With Schizophrenia and Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features
ClinicalTrials.gov ID: NCT00102518
Acronym / sponsor ID: APEX 241 / 31-03-241
Conditions: Schizophrenia, Bipolar Disorder
Keywords: Open Label, Aripiprazole, Bipolar I Disorder, Manic or Mixed Episode
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 325 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2004
Primary completion: Feb 2007 (actual)
Study completion: Feb 2007 (actual)
First posted: 31 Jan 2005 (estimated)
Results: Posted 31 Aug 2012

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NCT00102063 and NCT00110461 Subjects	Experimental	Drug: AripiprazoleAll subjects had either completed or had withdrawn from the double-blind extension phase of study NCT00110461 (OPDC 31-03-240) and study NCT00102063 (OPDC 31-03-239).

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Adolescent patients with schizophrenia, or child and adolescent patients with bipolar I disorder, manic or mixed episode

Key exclusion criteria (2 listed)

Patients with a co-morbid serious, uncontrolled systemic illness
Patients with a significant risk of committing suicide

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
AripiprazoleAlso: OPC-145972 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses	Drug	NCT00102063 and NCT00110461 Subjects

Primary outcome

Percentage of Subjects Experiencing SAEs
Time frame: Baseline and Week 23
Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.

2 secondary outcomes

Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline and Week 26
Change in Young Mania Rating Scale (Y-MRS) Total Score
Time frame: Baseline and Week 26

Results and safety

Results posted to the registry on 31 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
NCT00102063 and NCT00110461 Subjects	325	238

Primary outcome: Percentage of Subjects Experiencing SAEs

Time frame: Baseline and Week 23. Number. Unit: percentage of participants

Measure	NCT00102063 and NCT00110461 Subjects n = 325
Value	6.2

Population analysed: All enrolled subjects.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected as spontaneous reports at all scheduled visit. 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
NCT00102063 and NCT00110461 Subjects	20 of 325 (6.2%)	230 of 325 (70.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Schizophrenia

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.

The record lists no contact. Use the official record to reach the sponsor.

50 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Schizophrenia and Bipolar Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 50 sites in United States.

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 2 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 31 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 50 sites in United States. 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 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 31 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?

Percentage of Subjects Experiencing SAEs (time frame: Baseline and Week 23). 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 NCT00102518.

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 31 Aug 2012.