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SchizophreniaPhase 3ASPIRENCT01129882

An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Participants With Schizophrenia

A Phase 3 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 157 sites in 24 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 primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
709 participants
Where
157 sitesin 24 countries
Study dates
24 Jun 2010to 6 Dec 2018
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
  • Participants who, in the investigator's judgment, may benefit from continued participation in an aripiprazole IM Depot study.
  • The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the first injection for Study 270 must occur within 4 weeks (which was defined as 28 [-2/+10] days) of the last injection in Study 248.
  • Participants who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by an Independent Review Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any protocol-required procedures.
  • Participants able to understand the nature of the study and follow protocol requirements and who can read and understand the written word in order to complete patient-reported outcomes measures.
  • Outpatient status.

Who cannot join

  • Participants with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic, or other cognitive disorders.
  • Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
  • Participants who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine.
  • Participants with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
  • Participants who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Show all 10Show fewer
  • Electroconvulsive therapy within 180 days prior to entry.
  • Any participant who requires or may need any other antipsychotic medications during the course of the study.
  • Aripiprazole IM Depot (including generic formulation) is commercially available in the participant's country.
  • Other protocol specific inclusion/exclusion criteria may apply.

Trial locations and contacts

157 sites in 24 countries.

157 sites in 24 countries

United States52 sites

  • Study site

    Akron, Ohio

  • Study site

    Allentown, Pennsylvania, 18104

  • Study site

    Austin, Texas, 78731

  • Study site

    Austin, Texas, 78754

  • Study site

    Bellevue, California, 98007

  • Study site

    Bothell, Washington, 98011

  • Study site

    Bradenton, Florida

  • Study site

    Buffalo, New York, 14215

  • Study site

    Canton, Ohio, 44718

  • Study site

    Charleston, South Carolina, 29401

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60640

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Doral, Florida

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Garden Grove, California, 92845

  • Study site

    Glendale, California, 91204

  • Study site

    Glendale, California, 91206

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Homestead, Florida, 33030

  • Study site

    Imperial, California, 92251

  • Study site

    Indianapolis, Indiana, 46222

  • Study site

    Jenkintown, Pennsylvania, 19046

  • Study site

    Los Angeles, California, 90024

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    National City, California, 91950

  • Study site

    National City, California

  • Study site

    New York, New York, 10035

  • Study site

    North Platte, Nebraska, 69101

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orange, California, 92868

  • Study site

    Orange City, Florida, 32763

  • Study site

    Pasadena, California, 91107

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Pico Rivera, California

  • Study site

    Queens, New York

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Rochester, New York, 14615

  • Study site

    San Bernardino, California, 92408-3304

  • Study site

    San Diego, California

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Sherman Oaks, California, 91403

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    St Louis, Missouri, 63109

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43609

  • Study site

    Washington D.C., District of Columbia, 20016

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Bulgaria14 sites

  • Study site

    Burgas, 8000

  • Study site

    Lovech, 5500

  • Study site

    Pazardzhik, 4400

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Plovdiv

  • Study site

    Radnevo, 6260

  • Study site

    Rousse, 7003

  • Study site

    Sofia, 1113

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1632

  • Study site

    Tserova Koria

  • Study site

    Varna, 9001

  • Study site

    Varna

Other trials in Bulgaria

Russia9 sites

  • Study site

    Lipetsk, 398007

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 127083

  • Study site

    Nizhny Novgorod, 603152

  • Study site

    Nizhny Novgorod, 603155

  • Study site

    Saint Petersburg, 190121

  • Study site

    Saint Petersburg, 192019

  • Study site

    Saint Petersburg

  • Study site

    Smolensk

Other trials in Russia

Chile8 sites

  • Study site

    Santiago, 7500710

  • Study site

    Santiago, 7510186

  • Study site

    Santiago, 7580307

  • Study site

    Santiago, 8330838

  • Study site

    Santiago, 8780000

  • Study site

    Santiago, 8900085

  • Study site

    Temuco, 4781151

  • Study site

    Valdivia, 5090145

Other trials in Chile

Poland8 sites

  • Study site

    Bełchatów, 97-400

  • Study site

    Bialystok, 15-879

  • Study site

    Bydgoszcz, 85096

  • Study site

    Choroszcz, 16-070

  • Study site

    Krakow, 31-501

  • Study site

    Leszno, 64-100

  • Study site

    Sosnowiec, 41-200

  • Study site

    Wroclaw, 50-227

Other trials in Poland

India7 sites

  • Study site

    Ahmedabad, Gujarat, 380006

  • Study site

    Bangalore

  • Study site

    Chennai

  • Study site

    Kanpur, 208005

  • Study site

    Mangalore, Karnataka, 575018

  • Study site

    Pune, 411004

  • Study site

    Tirupati, 517507

Other trials in India

Romania6 sites

  • Study site

    Arad, 310022

  • Study site

    Bucharest, 41914

  • Study site

    Cluj-Napoca, 400012

  • Study site

    Craiova, 200620

  • Study site

    Oradea, 410163

  • Study site

    Piteşti, 110069

Other trials in Romania

Argentina5 sites

  • Study site

    Buenos Aires, 1900

  • Study site

    Buenos Aires, C1058AAH

  • Study site

    Buenos Aires, C1405BOA

  • Study site

    Buenos Aires, C1425AHQ

  • Study site

    Mendoza, M5500HYF

Other trials in Argentina

Estonia5 sites

  • Study site

    Tallinn, 10614

  • Study site

    Tallinn, 10617

  • Study site

    Tartu, 50417

  • Study site

    Tartu

  • Study site

    Viljandi, 71024

Other trials in Estonia

Mexico5 sites

  • Study site

    Culiacán, Sinaloa, 80020

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    México, 7760

  • Study site

    Monterrey, Nuevo León, 64040

  • Study site

    San Luis Potosí City, 78218

Other trials in Mexico

Slovakia5 sites

  • Study site

    Bardejov

  • Study site

    Košice, 041 90

  • Study site

    Liptovský Mikuláš, 3101

  • Study site

    Prešov

  • Study site

    Rimavská Sobota

Other trials in Slovakia

Malaysia4 sites

  • Study site

    Ipoh

  • Study site

    Kajang

  • Study site

    Kuala Lumpur, 56000

  • Study site

    Kuala Lumpur, 59100

Other trials in Malaysia

South Korea4 sites

  • Study site

    Daejeon, 301-721

  • Study site

    Gwangju, 501-757

  • Study site

    Incheon, 400-711

  • Study site

    Seoul, 110-744

Other trials in South Korea

Australia3 sites

  • Study site

    Epping, Victoria, 3076

  • Study site

    Frankston, Victoria, 3199

  • Study site

    Fremantle, Western Australia, 6959

Other trials in Australia

Croatia3 sites

  • Study site

    Zagreb, 10000

  • Study site

    Zagreb, 10090

  • Study site

    Zagreb

Other trials in Croatia

Hungary3 sites

  • Study site

    Baja, 6500

  • Study site

    Balassagyarmat, 2660

  • Study site

    Gyõr, 9023

Other trials in Hungary

Philippines3 sites

  • Study site

    Iloilo City, Western Visayas, 5000

  • Study site

    Mandaluyong, NCR, 1553

  • Study site

    Mariveles

Other trials in Philippines

South Africa3 sites

  • Study site

    Bellville, 7530

  • Study site

    Cape Town, Western Province, 7530

  • Study site

    Pretoria West, 1

Other trials in South Africa

Spain3 sites

  • Study site

    Barcelona, 08006

  • Study site

    Barcelona, 8036

  • Study site

    L'Hospitalet de Llobregat

Other trials in Spain

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kragujevac, 34000

Other trials in Serbia

Taiwan2 sites

  • Study site

    Tainan, 704

  • Study site

    Taipei, 110

Other trials in Taiwan

Finland1 site

  • Study site

    Helsinki, 250

Other trials in Finland

Puerto Rico1 site

  • Study site

    San Juan, 00918

Other trials in Puerto Rico

Thailand1 site

  • Study site

    Chiang Mai

Other trials in Thailand

About this study

Official title: An Open-Label, Multicenter, Rollover, Long-term Study of Aripiprazole Intramuscular Depot in Patients With Schizophrenia

The primary objective of this study was to continue to provide aripiprazole intramuscular (IM) depot treatment (400 milligrams [mg] or 300 mg) to participants with schizophrenia completing the 52-week, open-label safety and tolerability Study 31-08-248. In addition, the secondary objective was to collect additional long-term safety data on aripiprazole IM depot treatment.

Read the detailed description

This was an open-label study that enrolled participants with schizophrenia who had completed the 52-week, open-label safety and tolerability Study 31-08-248 and continued to provide aripiprazole IM depot treatment.

Participants received this treatment until aripiprazole IM Depot was commercially available in any dosage (including generic formulations) in the country where the study was being conducted or the commercial availability of aripiprazole IM Depot was terminated by the sponsor, or until the study completion date of 06 Dec 2018 was reached.

Eligible participants entered this study at the end of treatment visit (Week 52) of Study 31-08-248. Participants continued to receive aripiprazole IM depot every month (study months were every 4 weeks, which were defined as 28 [-2/+10] days) as a continuation of their previous monthly dose in Study 31-08-248.

Conditions
Schizophrenia
Being tested
Aripiprazole
Keywords
Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

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

Study groups in NCT01129882
Study groupRoleWhat they receive
Aripiprazole IM depotExperimentalActive treatment of monthly doses of aripiprazole IM depot (300 mg or 400 mg)
Receives: Drug: Aripiprazole

What is being measured

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

  1. Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE)

    A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity.

    A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Baseline to Month 97 (+/- 3 days)

Secondary outcomes (1)

  1. Mean Change In Clinical Global Impression-Severity (CGI-S) of Illness Scale Score From Baseline To Last Visit

    The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The Last Visit was defined as the last available post-baseline evaluation. A decrease in the CGI-S score indicated disease stability or improvement.

    Measured: Baseline, Month 91

Timeline

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

  1. First posted25 May 2010 (estimated)
  2. Study start24 Jun 2010
  3. Primary completion6 Dec 2018
  4. Study completion6 Dec 2018

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
709 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01129882
Sponsor's protocol ID
31-10-270
Acronym
ASPIRE
Status last verified
Dec 2019
First submitted
22 May 2010
Last updated
6 Jan 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 157 sites in 24 countries.

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 6 inclusion and 10 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, Bulgaria, Russia, Chile, Poland and 19 more countries. 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 6 Jan 2020). 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?

Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE) (time frame: Baseline to Month 97 (+/- 3 days)). 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 NCT01129882.

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 6 Jan 2020.

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