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SchizophreniaPhase 3ASPIRENCT00706654

Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

A Phase 3 study testing Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally and Aripiprazole depot 25 or 50 mg in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 98 sites in 15 countries.

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 purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally and Aripiprazole depot 25 or 50 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
937 participants
Where
98 sitesin 15 countries
Study dates
1 Sep 2008to 1 Aug 2012
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

98 sites in 15 countries.

98 sites in 15 countries

United States39 sites

  • Study site

    Arlington, Texas, 76011

  • Study site

    Austin, Texas, 78756

  • Study site

    Buffalo, New York, 14213

  • Study site

    Cerritos, California, 90703

  • Study site

    Charleston, South Carolina, 29401

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Escondido, California, 92025

  • Study site

    Gainesville, Florida, 32608

  • Study site

    Garden Grove, California, 92845

  • Study site

    Garfield Heights, Ohio, 44125

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    Johnson City, Tennessee, 37614-1707

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Nashville, Tennessee, 37212

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10035

  • Study site

    Oak Brook, Illinois, 60523

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Orange, California, 92868-3298

  • Study site

    Orange, California, 92868

  • Study site

    Pasadena, California, 91106

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Plantation, Florida, 33317

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Rochester, New York, 14624

  • Study site

    San Diego, California, 92102

  • Study site

    San Diego, California, 92103-8620

  • Study site

    San Diego, California, 92123

  • Study site

    Shreveport, Louisiana, 71104

  • Study site

    South Carolina, North Carolina, 29425

  • Study site

    Tampa, Florida, 33613

  • Study site

    Toledo, Ohio, 43609

  • Study site

    Torrance, California, 90502

  • Study site

    Towson, Maryland, 21286

  • Study site

    Washington D.C., District of Columbia, 20016

Other trials in United States

Poland9 sites

  • Study site

    Bełchatów, 97-400

  • Study site

    Bialystok, 15-879

  • Study site

    Bydgoszcz, 85-096

  • Study site

    Choroszcz, 16-070

  • Study site

    Krakow, 31-501

  • Study site

    Leszno, 64-100

  • Study site

    Pruszków, 05-802

  • Study site

    Sosnowiec, 41-200

  • Study site

    Wroclaw, 50-227

Other trials in Poland

Bulgaria8 sites

  • Study site

    Burgas, 8000

  • Study site

    Pazardzhik, 4400

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4000

  • Study site

    Sofia, 1113

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1632

  • Study site

    Varna, 9000

Other trials in Bulgaria

Chile8 sites

  • Study site

    Santiago, 7500710

  • Study site

    Santiago, 7510041

  • Study site

    Santiago, 7510186

  • Study site

    Santiago, 8053095

  • Study site

    Santiago, 8330838

  • Study site

    Santiago, 8900085

  • Study site

    Temuco, 4781151

  • Study site

    Valdivia, 5090145

Other trials in Chile

South Korea7 sites

  • Study site

    Busan, 614-735

  • Study site

    Daejeon, 301-721

  • Study site

    Gwangju, 501-757

  • Study site

    Incheon, 400-711

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 150-950

Other trials in South Korea

Estonia6 sites

  • Study site

    Jämejala, Viljandimaa, 71024

  • Study site

    Meegomäe, 65526

  • Study site

    Tallinn, 10613

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 50406

  • Study site

    Tartu, 50417

Other trials in Estonia

France4 sites

  • Study site

    Bully-les-Mines, 62160

  • Study site

    Élancourt, 78990

  • Study site

    Rennes, 35703

  • Study site

    Saint-Nazaire, 44606

Other trials in France

Hungary4 sites

  • Study site

    Baja, 6500

  • Study site

    Balassagyarmat, 2660

  • Study site

    Cegléd, 2700

  • Study site

    Győőor, 9024

Other trials in Hungary

Italy3 sites

  • Study site

    Milan, 20142

  • Study site

    Milan, 20157

  • Study site

    Pisa, 56126

Other trials in Italy

Thailand3 sites

  • Study site

    Bangkok, 10330

  • Study site

    Muang, Chiangmai, 50100

  • Study site

    Muang, Chiangmai, 50200

Other trials in Thailand

Croatia2 sites

  • Study site

    Zagreb, 10 090

  • Study site

    Zagreb, 10000

Other trials in Croatia

South Africa2 sites

  • Study site

    Cape Town, Western Province, 7530

  • Study site

    Pretoria, Gauteng, 0001

Other trials in South Africa

Austria1 site

  • Study site

    Innsbruck, A-6020

Other trials in Austria

Belgium1 site

  • Study site

    Bruges, 8200

Other trials in Belgium

Puerto Rico1 site

  • Study site

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia

The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

Read the detailed description

This will be a randomized, double-blind, active-controlled study consisting of a screening phase and 3 treatment phases. Eligibility will be determined during a screening phase of 2 to 42 days. Subjects currently receiving oral treatment with an anti-psychotic other than non-generic aripiprazole will enter Phase 1, and subjects with a lapse in aripiprazole or other anti-psychotic treatment at the time of study entry ("lapse" defined as > 3 consecutive days without medication) will enter directly into Phase 2.

During Phase 1 (oral conversion), subjects will be cross-titrated during weekly visits from other anti-psychotics to oral non-generic aripiprazole monotherapy over a minimum of 4 weeks and a maximum of 6 weeks. During Phase 2 (that will be a minimum of 8 weeks and a maximum of 28 weeks in duration), subjects will be assessed bi-weekly and stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria are met at Phase 2, subjects are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. Subjects will be randomized with a 2:2:1 (aripiprazole IM depot 300-400 mg monthly, oral aripiprazole 10-30 mg daily, aripiprazole IM depot 25-50 mg monthly). During Phase 3 subjects will be assessed for impending relapse/exacerbation of psychotic symptoms. If a subject is identified with impending relapse/exacerbation of psychotic symptoms, they will be withdrawn from the trial and given the opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549). Alternatively, any subject that discontinues in Phase 3 (up to and including Week 38) will have the option to enroll into an open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549).

The enrollment figure includes re-screened patients.

Conditions
Schizophrenia
Being tested
Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, Aripiprazole depot 25 or 50 mg, Placebo depot, Placebo tablets
Keywords
Aripiprazole, Intramuscular (IM) depot, Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

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

  • Aripiprazole depot 300 or 400 mgDrug

    Also called Abilify

    Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.

  • Aripiprazole 10-30 mg orallyDrug

    Also called Abilify

    Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.

  • Aripiprazole depot 25 or 50 mgDrug

    Also called Abilify

    Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.

  • Placebo depotDrug

    Placebo depot was supplied in lyophilized vials.

  • Placebo tabletsDrug

    Placebo tablets were identical in appearance to the aripiprazole tablets.

Study groups in NCT00706654
Study groupRoleWhat they receive
Aripiprazole depot 300 or 400 mgExperimentalPatients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.
Receives: Drug: Aripiprazole depot 300 or 400 mg; Drug: Placebo tablets
Aripiprazole 10-30 mg orallyActive comparatorPatients received aripiprazole 10-30 mg orally daily for 38 weeks.
Receives: Drug: Aripiprazole 10-30 mg orally; Drug: Placebo depot
Aripiprazole depot 25 or 50 mgExperimentalPatients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.
Receives: Drug: Aripiprazole depot 25 or 50 mg; Drug: Placebo tablets

What is being measured

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

  1. Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26

    A patient had exacerbation of psychotic symptoms/impending relapse if they met any of the following 4 criteria. 1) Clinical Global Impression of Improvement score ≥ 5 and either an increase on any of the following Positive and Negative Syndrome Scale (PANSS) items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) to a score > 4 with an increase of ≥ 2 on that item since randomization or an increase on any of the same PANSS items to a score > 4 and an increase of ≥ 4 on the same combined PANSS items since randomization, 2) Hospitalization due to worsening of psychotic symptoms, 3) Clinical Global Impression of Severity of Suicide (CGI-SS) score of 4 or 5 on Part 1 and/or 6 or 7 on Part 2, or 4) Violent behavior resulting in clinically significant self-injury, injury to another person, or property damage.

    Measured: Baseline to Week 26

Secondary outcomes (3)

  1. Time to Exacerbation of Psychotic Symptoms/Impending Relapse

    Measured: Baseline to the end of the study (Week 38)

  2. Percentage of Responders up to Week 38

    A patient was considered to be a responder if all of the following criteria were met. 1) Outpatient status, 2) PANSS total score ≤ 80, 3) Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): Conceptual disorganization, suspiciousness, hallucinatory behavior, unusual thought content, and 4) Clinical Global Impression of Severity of Illness (CGI-S) ≤ 4 (moderately ill) and 5) CGI-SS ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2.

    Measured: Baseline to the end of the study (Week 38)

  3. Percentage of Patients Achieving Remission

    A patient was considered to have achieved remission if they had a score of ≤ 3 on each of the following PANSS items, maintained for a period of 6 months: Delusions (P1), unusual thought content (G9), hallucinatory behavior (P3), conceptual disorganization (P2), mannerisms/posturing (G5), blunted affect (N1), social withdrawal (N4), and lack of spontaneity (N6).

    Measured: Baseline to the end of the study (Week 38)

Timeline

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

  1. First posted27 Jun 2008 (estimated)
  2. Study start1 Sep 2008
  3. Primary completion1 Aug 2012
  4. Study completion1 Aug 2012

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
937 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00706654
Sponsor's protocol ID
31-07-247
Acronym
ASPIRE
Status last verified
May 2026
First submitted
25 Jun 2008
Last updated
4 Jun 2026
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Kane JM, Sanchez R, Baker RA, Eramo A, Peters-Strickland T, Perry PP, Johnson BR, Tsai LF, Carson WH, McQuade RD, Fleischhacker WW. Patient-Centered Outcomes with Aripiprazole Once-Monthly for Maintenance Treatment in Patients with Schizophrenia: Results From Two Multicenter, Randomized, Double-Blind Studies. Clin Schizophr Relat Psychoses. 2015 Summer;9(2):79-87. Epub 2015 Feb 24.

    PubMed 25711509

  • Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, Kane JM. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.

    PubMed 24925984

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally and Aripiprazole depot 25 or 50 mg in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 98 sites in 15 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 5 inclusion and 15 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Poland, Bulgaria, Chile, South Korea and 10 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 14 Aug 2013). 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 Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26 (time frame: Baseline to Week 26). 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 NCT00706654, which also lists 2 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 4 Jun 2026.

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