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

Information source: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Aripiprazole depot 300 or 400 mg (Drug); Aripiprazole 10-30 mg orally (Drug); Aripiprazole depot 25 or 50 mg (Drug); Placebo depot (Drug); Placebo tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Otsuka Pharmaceutical Development & Commercialization, Inc.

Official(s) and/or principal investigator(s):
Raymond Sanchez, MD, Study Director, Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria by the End of Week 26

Secondary outcome:

Time to Exacerbation of Psychotic Symptoms/Impending Relapse

Percentage of Responders up to Week 38

Percentage of Patients Achieving Remission

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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


- 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


- 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.

Locations and Contacts

Innsbruck A-6020, Austria

Brugge 8200, Belgium

Bourgas 8000, Bulgaria

Pazardjik 4400, Bulgaria

Pleven 5800, Bulgaria

Plovdiv 4000, Bulgaria

Sofia 1632, Bulgaria

Sofia 1431, Bulgaria

Sofia 1113, Bulgaria

Varna 9000, Bulgaria

Santiago 8900085, Chile

Santiago 7500710, Chile

Santiago 7510041, Chile

Santiago 7510186, Chile

Santiago 8053095, Chile

Santiago 8330838, Chile

Temuco 4781151, Chile

Valdivia 5090145, Chile

Zagreb 10 090, Croatia

Zagreb 10000, Croatia

Meegomäe 65526, Estonia

Tallinn 10613, Estonia

Tallinn 13419, Estonia

Tartu 50406, Estonia

Tartu 50417, Estonia

Bully Les Mines 62160, France

Elancourt 78990, France

Rennes 35703, France

Saint Nazaire 44606, France

Baja 6500, Hungary

Balassagyarmat 2660, Hungary

Cegléd 2700, Hungary

Győőor 9024, Hungary

Milano 20142, Italy

Milano 20157, Italy

Pisa 56126, Italy

Busan 614-735, Korea, Republic of

Daejeon 301-721, Korea, Republic of

Gwangju 501-757, Korea, Republic of

Incheon 400-711, Korea, Republic of

Seoul 150-950, Korea, Republic of

Seoul 137-701, Korea, Republic of

Seoul 110-744, Korea, Republic of

Belchatow 97-400, Poland

Bialystok 15-879, Poland

Bydgoszcz 85-096, Poland

Choroszcz 16-070, Poland

Krakow 31-501, Poland

Leszno 64-100, Poland

Pruszków 05-802, Poland

Sosnowiec 41-200, Poland

Wroclaw 50-227, Poland

San Juan 00918, Puerto Rico

Bangkok 10330, Thailand

Cerritos, California 90703, United States

Escondido, California 92025, United States

Garden Grove, California 92845, United States

Oceanside, California 92056, United States

Orange, California 92868-3298, United States

Orange, California 92868, United States

Pasadena, California 91106, United States

Pico Rivera, California 90660, United States

San Diego, California 92102, United States

San Diego, California 92103-8620, United States

San Diego, California 92123, United States

Torrance, California 90502, United States

Muang, Chiangmai 50100, Thailand

Muang, Chiangmai 50200, Thailand

Washington, District of Columbia 20016, United States

Gainesville, Florida 32608, United States

Kissimmee, Florida 34741, United States

Plantation, Florida 33317, United States

Tampa, Florida 33613, United States

Pretoria, Gauteng 0001, South Africa

Chicago, Illinois 60612, United States

Oak Brook, Illinois 60523, United States

Shreveport, Louisiana 71104, United States

Towson, Maryland 21286, United States

Kansas City, Missouri 64108, United States

Buffalo, New York 14213, United States

New York, New York 10003, United States

New York, New York 10035, United States

Rochester, New York 14624, United States

Hickory, North Carolina 28601, United States

South Carolina, North Carolina 29425, United States

Garfield Heights, Ohio 44125, United States

Toledo, Ohio 43609, United States

Oklahoma City, Oklahoma 73112, United States

Charleston, South Carolina 29401, United States

Charleston, South Carolina 29407, United States

Johnson City, Tennessee 37614-1707, United States

Nashville, Tennessee 37212, United States

Arlington, Texas 76011, United States

Austin, Texas 78756, United States

Jamejala, Viljandi County 71024, Estonia

Richmond, Virginia 23230, United States

Cape Town, Western Province 7530, South Africa

Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: September 2008
Last updated: July 12, 2013

Page last updated: August 20, 2015

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