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