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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 (Drug); Placebo depot (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 trial was to evaluate the efficacy, safety, and tolerability of an intramuscular depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia. The trial was designed into 4 treatment phases. Phase 1 was designed to allow for a patient to be converted from their current antipsychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2, the patient was stabilized on oral non-generic aripiprazole monotherapy (oral stabilization phase from a minimum of 4 weeks to a maximum of 12 weeks). Once the patient was stabilized in Phase 2, they entered Phase 3, the single-blind intramuscular (IM) depot aripiprazole stabilization phase. The goal of the phase was to stabilize the patient on the IM depot aripiprazole formulation for a minimum of 12 weeks to a maximum of 36 weeks. When the patient was stabilized, they were eligible to be randomized into the double-blind IM depot maintenance phase (Phase 4). During Phase 4, the patient was assessed for exacerbation of psychotic symptoms and/or impending relapse for up to 52 weeks.

Clinical Details

Official title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

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

Primary outcome: Time to Exacerbation of Psychotic Symptoms/Impending Relapse

Secondary outcome:

Percentage of Patients Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria

Percentage of Responders

Percentage of Patients Achieving Remission

Mean Change From Baseline in the PANSS Total Score

Mean Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score

Mean Change From Baseline in the PANSS Positive Subscale Score

Mean Change From Baseline in the PANSS Negative Subscale Score

Mean Clinical Global Impression-Improvement (CGI-I) Score

Time to Discontinuation

Detailed description: This was a randomized, double-blind, placebo-controlled study consisting of a screening phase and 4 treatment phases. Eligibility was determined during a screening phase of 2 to 42 days. Patients receiving oral treatment with an antipsychotic other than non-generic aripiprazole entered Phase 1. Patients with a lapse in aripiprazole or other antipsychotic treatment at the time of study entry ("lapse" defined as > 3 consecutive days without medication) entered directly into Phase 2. During Phase 1 (oral conversion), patients were cross-titrated during weekly visits from other antipsychotics to oral non-generic aripiprazole monotherapy over a minimum of 4 weeks and a maximum of 6 weeks. During Phase 2 (a minimum of 4 weeks and a maximum of 12 weeks in duration), patients were assessed bi-weekly and stabilized on an oral dose of aripiprazole ranging from 10 mg to 30 mg daily. After stability criteria were met in Phase 2, patients entered the single-blind aripiprazole intramuscular (IM) depot stabilization phase, Phase 3. In Phase 3, patients were stabilized on aripiprazole IM depot for 12 consecutive weeks. Once the patient met the stability criteria, they were eligible to be randomized into the double-blind phase, Phase 4. Patients were randomized in a 2: 1 ratio (aripiprazole IM depot vs placebo IM depot) stratified by region and last aripiprazole IM depot injection dose level in Phase 3. During Phase 4, patients were assessed for impending relapse/exacerbation of psychotic symptoms. If a patient was identified with impending relapse/exacerbation of psychotic symptoms, they were withdrawn from the trial and given the opportunity to enroll into an open-label aripiprazole IM depot trial, 31-08-248. Patients that completed Phase 4 (up to and including Week 52) had the option to enroll into an open-label aripiprazole IM depot trial, 31-08-248 (NCT00731549).

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 the Institutional Review Board/Institutional 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, 4th edition 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

antipsychotic 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 outcomes 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, or 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 antipsychotic agents.

- 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 them to undue risk or interfere with study assessments.

- Subjects who are involuntary incarcerated.

- Subjects who have used an investigational agent within 30 days of screening or prior

participation in a clinical study with aripiprazole IM depot.

- Subjects with clinically significant abnormalities in laboratory test results, vital

signs, or ECG results; and subjects hospitalized for more than 30 days in the 90 days prior to Phase 1.

- 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/or Phase 1.

Locations and Contacts

Otsuka Investigational Site, Buenos Aires C1425AHQ, Argentina

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Additional Information

Starting date: July 2008
Last updated: June 16, 2013

Page last updated: August 20, 2015

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