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

NCT00706654 | Completed Phase 3 Results DMC

• 1 other identifier: 31-07-247
• Study Type: interventional
• Target: 937
• Locations: 15 countries
• Sites: 98

Brief 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. 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.

Conditions

Schizophrenia

Keywords

Aripiprazole; Intramuscular (IM) depot; Schizophrenia

Outcome Measures

Primary Outcomes (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.

  Baseline to Week 26

Secondary Outcomes (3)

• Time to Exacerbation of Psychotic Symptoms/Impending Relapse

  Baseline to the end of the study (Week 38)

• Percentage of Responders up to Week 38

  Baseline to the end of the study (Week 38)

• Percentage of Patients Achieving Remission

  Baseline to the end of the study (Week 38)

Study Arms (3)

Aripiprazole depot 300 or 400 mg

EXPERIMENTAL

Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.

Drug: Aripiprazole depot 300 or 400 mg; Drug: Placebo tablets

Aripiprazole 10-30 mg orally

ACTIVE COMPARATOR

Patients received aripiprazole 10-30 mg orally daily for 38 weeks.

Drug: Aripiprazole 10-30 mg orally; Drug: Placebo depot

Aripiprazole depot 25 or 50 mg

EXPERIMENTAL

Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.

Drug: Aripiprazole depot 25 or 50 mg; Drug: Placebo tablets

Interventions

Aripiprazole depot 300 or 400 mg DRUG

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

Also known as: Abilify

Aripiprazole depot 300 or 400 mg

Aripiprazole 10-30 mg orally DRUG

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.

Also known as: Abilify

Aripiprazole 10-30 mg orally

Aripiprazole depot 25 or 50 mg DRUG

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

Also known as: Abilify

Aripiprazole depot 25 or 50 mg

Placebo depot DRUG

Placebo depot was supplied in lyophilized vials.

Aripiprazole 10-30 mg orally

Placebo tablets DRUG

Placebo tablets were identical in appearance to the aripiprazole tablets.

Aripiprazole depot 25 or 50 mg; Aripiprazole depot 300 or 400 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (98)

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Cerritos, California, 90703, United States

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Escondido, California, 92025, United States

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Garden Grove, California, 92845, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868-3298, United States

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Orange, California, 92868, United States

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Pasadena, California, 91106, United States

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Pico Rivera, California, 90660, United States

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San Diego, California, 92102, United States

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San Diego, California, 92103-8620, United States

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San Diego, California, 92123, United States

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Torrance, California, 90502, United States

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

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Gainesville, Florida, 32608, United States

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Kissimmee, Florida, 34741, United States

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Plantation, Florida, 33317, United States

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Tampa, Florida, 33613, United States

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Chicago, Illinois, 60612, United States

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Oak Brook, Illinois, 60523, United States

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Shreveport, Louisiana, 71104, United States

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Towson, Maryland, 21286, United States

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Kansas City, Missouri, 64108, United States

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Buffalo, New York, 14213, United States

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New York, New York, 10003, United States

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New York, New York, 10035, United States

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Rochester, New York, 14624, United States

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Hickory, North Carolina, 28601, United States

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South Carolina, North Carolina, 29425, United States

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Garfield Heights, Ohio, 44125, United States

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Toledo, Ohio, 43609, United States

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Oklahoma City, Oklahoma, 73112, United States

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Charleston, South Carolina, 29401, United States

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Charleston, South Carolina, 29407, United States

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Johnson City, Tennessee, 37614-1707, United States

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Nashville, Tennessee, 37212, United States

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Arlington, Texas, 76011, United States

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Austin, Texas, 78756, United States

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Richmond, Virginia, 23230, United States

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Milwaukee, Wisconsin, 53226, United States

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Innsbruck, A-6020, Austria

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Bruges, 8200, Belgium

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Burgas, 8000, Bulgaria

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Pazardzhik, 4400, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4000, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1632, Bulgaria

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Varna, 9000, Bulgaria

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Santiago, 7500710, Chile

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Santiago, 7510041, Chile

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Santiago, 7510186, Chile

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Santiago, 8053095, Chile

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Santiago, 8330838, Chile

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Santiago, 8900085, Chile

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Temuco, 4781151, Chile

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Valdivia, 5090145, Chile

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Zagreb, 10 090, Croatia

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Zagreb, 10000, Croatia

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Jämejala, Viljandimaa, 71024, Estonia

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Meegomäe, 65526, Estonia

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Tallinn, 10613, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50406, Estonia

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Tartu, 50417, Estonia

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Bully-les-Mines, 62160, France

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Élancourt, 78990, France

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Rennes, 35703, France

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Saint-Nazaire, 44606, France

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Baja, 6500, Hungary

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Balassagyarmat, 2660, Hungary

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Cegléd, 2700, Hungary

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Győőor, 9024, Hungary

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Milan, 20142, Italy

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Milan, 20157, Italy

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Pisa, 56126, Italy

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Bełchatów, 97-400, Poland

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Bialystok, 15-879, Poland

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Bydgoszcz, 85-096, Poland

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Choroszcz, 16-070, Poland

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Krakow, 31-501, Poland

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Leszno, 64-100, Poland

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Pruszków, 05-802, Poland

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Sosnowiec, 41-200, Poland

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Wroclaw, 50-227, Poland

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San Juan, 00918, Puerto Rico

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Pretoria, Gauteng, 0001, South Africa

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Cape Town, Western Province, 7530, South Africa

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Busan, 614-735, South Korea

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Daejeon, 301-721, South Korea

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Gwangju, 501-757, South Korea

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Incheon, 400-711, South Korea

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Seoul, 110-744, South Korea

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Seoul, 137-701, South Korea

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Seoul, 150-950, South Korea

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Muang, Chiangmai, 50100, Thailand

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Muang, Chiangmai, 50200, Thailand

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Bangkok, 10330, Thailand

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Related Publications (2)

• 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.

  PMID: 25711509 DERIVED

• 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.

  PMID: 24925984 DERIVED

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Clinical Transparency
• Organization: Otsuka

SMB_ClinicalTranspa@otsuka-us.com

1-800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: September 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 4, 2026
• Results First Posted: August 14, 2013

Record last verified: 2026-05

Locations

AU (1); BE (1); IT (3); PR (1); PL (9); ES (6); CR (2); TH (3); FR (4); BU (8); HU (4); KR (7); ZA (2); US (39); CL (8)