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Monthly shot may keep schizophrenia symptoms at bay

NCT ID NCT00706654

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a once-monthly injection of aripiprazole can help people with schizophrenia avoid a relapse of symptoms. Over 900 adults took part, first switching to oral aripiprazole, then receiving either the long-acting shot or another treatment for up to 38 weeks. The main goal was to see how many people experienced worsening symptoms or needed hospitalization.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

937 people

The number who actually took part.

Started

Sep 2008

Finished

Aug 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by Institutional Review Board/Independent Ethics Committee \[IRB/IEC\]), prior to the initiation of any protocol-required procedures. * Male and female subjects 18 to 60 years of age, inclusive, at time of informed consent. * Subjects with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, version 4, Text Revision (DSM-IV-TR) criteria and a history of the illness for at least 3 years prior to screening. * Subjects who, in the investigator's judgment, require chronic treatment with an anti-psychotic medication. * Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcome measures, and who can be reliably rated on assessment scales. Exclusion Criteria: * Subjects 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. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder. * Subjects with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine. * Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment. * Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or 2 positive drug screens for cocaine. * Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones, or hypersensitivity to anti-psychotic agents, including aripiprazole. * Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening. * Subjects with uncontrolled thyroid function abnormalities. * Subjects with a history of seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the subject to undue risk or interfere with study assessments. * Subjects who are involuntarily incarcerated. * Subjects who have undergone electroconvulsive therapy within 180 days of entry into Phase 2. * Subjects who have used an investigational agent within 30 days of screening; and prior participation in a clinical study with aripiprazole IM depot. * Subjects with clinically significant abnormalities in laboratory test results, vital signs, or ECG results. * Subjects hospitalized for more than 30 days in the 90 days prior to Phase 1 (or Phase 2 for subjects bypassing Phase 1). * Subjects requiring more than 1 benzodiazepine beyond screening (eg, lorazepam and oxazepam). * Subjects who fail to wash-out from prohibited concomitant medications, including the use of CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers, antipsychotics, antidepressants (including monoamine oxidase inhibitors \[MAOI\]), and mood stabilizers, during screening and Phase 1.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Study site

    Cerritos, California, 90703, United States

  • Study site

    Escondido, California, 92025, United States

  • Study site

    Garden Grove, California, 92845, United States

  • Study site

    Oceanside, California, 92056, United States

  • Study site

    Orange, California, 92868-3298, United States

  • Study site

    Orange, California, 92868, United States

  • Study site

    Pasadena, California, 91106, United States

  • Study site

    Pico Rivera, California, 90660, United States

  • Study site

    San Diego, California, 92102, United States

  • Study site

    San Diego, California, 92103-8620, United States

  • Study site

    San Diego, California, 92123, United States

  • Study site

    Torrance, California, 90502, United States

  • Study site

    Washington D.C., District of Columbia, 20016, United States

  • Study site

    Gainesville, Florida, 32608, United States

  • Study site

    Kissimmee, Florida, 34741, United States

  • Study site

    Plantation, Florida, 33317, United States

  • Study site

    Tampa, Florida, 33613, United States

  • Study site

    Chicago, Illinois, 60612, United States

  • Study site

    Oak Brook, Illinois, 60523, United States

  • Study site

    Shreveport, Louisiana, 71104, United States

  • Study site

    Towson, Maryland, 21286, United States

  • Study site

    Kansas City, Missouri, 64108, United States

  • Study site

    Buffalo, New York, 14213, United States

  • Study site

    New York, New York, 10003, United States

  • Study site

    New York, New York, 10035, United States

  • Study site

    Rochester, New York, 14624, United States

  • Study site

    Hickory, North Carolina, 28601, United States

  • Study site

    South Carolina, North Carolina, 29425, United States

  • Study site

    Garfield Heights, Ohio, 44125, United States

  • Study site

    Toledo, Ohio, 43609, United States

  • Study site

    Oklahoma City, Oklahoma, 73112, United States

  • Study site

    Charleston, South Carolina, 29401, United States

  • Study site

    Charleston, South Carolina, 29407, United States

  • Study site

    Johnson City, Tennessee, 37614-1707, United States

  • Study site

    Nashville, Tennessee, 37212, United States

  • Study site

    Arlington, Texas, 76011, United States

  • Study site

    Austin, Texas, 78756, United States

  • Study site

    Richmond, Virginia, 23230, United States

  • Study site

    Milwaukee, Wisconsin, 53226, United States

  • Study site

    Innsbruck, A-6020, Austria

  • Study site

    Bruges, 8200, Belgium

  • Study site

    Burgas, 8000, Bulgaria

  • Study site

    Pazardzhik, 4400, Bulgaria

  • Study site

    Pleven, 5800, Bulgaria

  • Study site

    Plovdiv, 4000, Bulgaria

  • Study site

    Sofia, 1113, Bulgaria

  • Study site

    Sofia, 1431, Bulgaria

  • Study site

    Sofia, 1632, Bulgaria

  • Study site

    Varna, 9000, Bulgaria

  • Study site

    Santiago, 7500710, Chile

  • Study site

    Santiago, 7510041, Chile

  • Study site

    Santiago, 7510186, Chile

  • Study site

    Santiago, 8053095, Chile

  • Study site

    Santiago, 8330838, Chile

  • Study site

    Santiago, 8900085, Chile

  • Study site

    Temuco, 4781151, Chile

  • Study site

    Valdivia, 5090145, Chile

  • Study site

    Zagreb, 10 090, Croatia

  • Study site

    Zagreb, 10000, Croatia

  • Study site

    Jämejala, Viljandimaa, 71024, Estonia

  • Study site

    Meegomäe, 65526, Estonia

  • Study site

    Tallinn, 10613, Estonia

  • Study site

    Tallinn, 13419, Estonia

  • Study site

    Tartu, 50406, Estonia

  • Study site

    Tartu, 50417, Estonia

  • Study site

    Bully-les-Mines, 62160, France

  • Study site

    Élancourt, 78990, France

  • Study site

    Rennes, 35703, France

  • Study site

    Saint-Nazaire, 44606, France

  • Study site

    Baja, 6500, Hungary

  • Study site

    Balassagyarmat, 2660, Hungary

  • Study site

    Cegléd, 2700, Hungary

  • Study site

    Győőor, 9024, Hungary

  • Study site

    Milan, 20142, Italy

  • Study site

    Milan, 20157, Italy

  • Study site

    Pisa, 56126, Italy

  • Study site

    Bełchatów, 97-400, Poland

  • Study site

    Bialystok, 15-879, Poland

  • Study site

    Bydgoszcz, 85-096, Poland

  • Study site

    Choroszcz, 16-070, Poland

  • Study site

    Krakow, 31-501, Poland

  • Study site

    Leszno, 64-100, Poland

  • Study site

    Pruszków, 05-802, Poland

  • Study site

    Sosnowiec, 41-200, Poland

  • Study site

    Wroclaw, 50-227, Poland

  • Study site

    San Juan, 00918, Puerto Rico

  • Study site

    Pretoria, Gauteng, 0001, South Africa

  • Study site

    Cape Town, Western Province, 7530, South Africa

  • Study site

    Busan, 614-735, South Korea

  • Study site

    Daejeon, 301-721, South Korea

  • Study site

    Gwangju, 501-757, South Korea

  • Study site

    Incheon, 400-711, South Korea

  • Study site

    Seoul, 110-744, South Korea

  • Study site

    Seoul, 137-701, South Korea

  • Study site

    Seoul, 150-950, South Korea

  • Study site

    Muang, Chiangmai, 50100, Thailand

  • Study site

    Muang, Chiangmai, 50200, Thailand

  • Study site

    Bangkok, 10330, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.