An Open-label, Safety and Tolerability Trial of Aripiprazole IM Depot Treatment Initiation in Adult Subjects With Schizophrenia Stabilized on Atypical Oral Antipsychotics Other Than Aripiprazole

Otsuka Pharmaceutical Development & Commercialization, Inc.10 sites in 1 country60 target enrollmentJanuary 2012

ConditionsSchizophrenia

InterventionsAripiprazole IM Depot

DrugsAripiprazole IM Depot

Overview

Phase: Phase 1
Intervention: Aripiprazole IM Depot
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrollment: 60
Locations: 10
Primary Endpoint: Number of Participants With Adverse Events (AE).
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will test the safety of an aripiprazole injection in subjects with schizophrenia that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in this study will receive one injection of aripiprazole and will need to stop taking their other antipsychotic medication two weeks after the injection. The study will last one month. Subjects will be required to come to a clinic for evaluations and drug and urine collection five times during the course of the study.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

April 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female individuals between 18 and 64 years of age, inclusive, with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria.
•Good physical health as determined by no clinically significant deviation from normal in medical history, clinical laboratory determination, ECGs, or physical examinations.
•Ability to provide written informed consent or consent obtained from a legally acceptable representative (as required by IRB) prior to the initiation of any protocol-required procedures.
•Body mass index of 18 to 35 kg/m2, inclusive.
•Prior history of tolerating aripiprazole.
•Subjects must be treated with one of the following atypical oral antipsychotic medications: risperidone, olanzapine, quetiapine, ziprasidone, or paliperidone and be clinically stable, per the investigator's judgment, for 14 days prior to the administration of aripiprazole IM depot

Exclusion Criteria

•Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or have not had an orchidectomy or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide. Note: Women of childbearing potential (WOCBP) are defined as all women unless they have had an oophorectomy or hysterectomy or have been postmenopausal for 12 consecutive months.
•Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine. Subjects with a positive drug screen for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana).a
•Subjects likely to require prohibited concomitant therapy during the trial, and use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
•Females who are pregnant or lactating.
•Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous IM depot trial within the last 6 months; or who had previously enrolled and received trial medication in an aripiprazole IM depot clinical trial.
•Any major surgery within 30 days prior to enrollment.
•Evidence of organ dysfunction or any clinically significant deviation from normal in physical, electrocardiographic, or clinical laboratory examinations.
•Subjects who have a significant risk of committing suicide based on history or routine psychiatric status examination
•Subjects currently in an acute relapse of schizophrenia.
•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.

Arms & Interventions

Aripiprazole IM Depot

Intervention: Aripiprazole IM Depot

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AE).

Time Frame: From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).

An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.

Secondary Outcomes

Change From Baseline in PANSS Positive Sub-scale Score for OC Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.(Baseline, Week 1, 2 and 4)
Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.(Baseline, Week 1, 2 and 4)
Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.(Baseline, Week 1, 2 and 4)
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
Change From Baseline in PANSS Negative Sub-scale Score for OC Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
Change From Baseline in CGI-S Score in LOCF Data.(Baseline, Week 1, 2 and 4.)
CGI-I Scale Score in LOCF Data.(Week 1, 2 and 4)
Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.(Week 1, 2, 4 and Last visit (Day 28).)