Clinical trial NCT01552772: Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Safety
Tolerability
Schizophrenia
Aripiprazole
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male and female individuals between 18 and 64 years of age, inclusive, with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria.
2. Good physical health as determined by no clinically significant deviation from normal in medical history, clinical laboratory determination, ECGs, or physical examinations.
3. 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.
4. Body mass index of 18 to 35 kg/m2, inclusive.
5. Prior history of tolerating aripiprazole.
6. 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:

1. 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.
2. 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
3. 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.
4. Females who are pregnant or lactating.
5. 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.
6. Any major surgery within 30 days prior to enrollment.
7. Evidence of organ dysfunction or any clinically significant deviation from normal in physical, electrocardiographic, or clinical laboratory examinations.
8. Subjects who have a significant risk of committing suicide based on history or routine psychiatric status examination
9. Subjects currently in an acute relapse of schizophrenia.
10. 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.
11. Subjects who were considered treatment-resistant to antipsychotic medication. (Subjects needed to have shown a previous response to an antipsychotic medication other than clozapine.)
12. Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
13. Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.

Primary outcomes:
measure: Number of Participants With Adverse Events (AE).
timeFrame: From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).
Secondary outcomes:
measure: Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.
timeFrame: Baseline, Week 1, 2, 4 and Last visit (Day 28).
measure: Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.
timeFrame: Baseline, Week 1, 2 and 4
measure: Change From Baseline in PANSS Positive Sub-scale Score for OC Data.
timeFrame: Baseline, Week 1, 2, 4 and Last visit (Day 28).
measure: Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.
timeFrame: Baseline, Week 1, 2 and 4
measure: Change From Baseline in PANSS Negative Sub-scale Score for OC Data.
timeFrame: Baseline, Week 1, 2, 4 and Last visit (Day 28).
measure: Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.
timeFrame: Baseline, Week 1, 2 and 4
measure: Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.
timeFrame: Baseline, Week 1, 2, 4 and Last visit (Day 28).
measure: Change From Baseline in CGI-S Score in LOCF Data.
timeFrame: Baseline, Week 1, 2 and 4.
measure: Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.
timeFrame: Week 1, 2, 4 and Last visit (Day 28).
measure: CGI-I Scale Score in LOCF Data.
timeFrame: Week 1, 2 and 4
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: South Coast Clinical Trials
state: California
city: Cerritos
country: United States
facility: Comprehensive Clinical Development
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Norwalk
country: United States
facility: South Coast Clinical Trials
state: California
city: San Diego
country: United States
facility: CNRI-San Diego
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Washington
country: United States
facility: Comprehensive Clinical Development
state: District of Columbia
city: Kissimmee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: St. Louis
country: United States
facility: St. Louis Clinical Trials
state: Missouri
city: Austin
country: United States
facility: Community Clinical Research
state: Texas
city: Dallas
country: United States
facility: Pillar Clinical Research
state: Texas
Study officials:
affiliation: Otsuka Pharmaceutical Development and Commercialization
name: Stacy Wu, MD
role: STUDY_DIRECTOR
References:
citation: Potkin SG, Raoufinia A, Mallikaarjun S, Bricmont P, Peters-Strickland T, Kasper W, Baker RA, Eramo A, Sanchez R, McQuade R. Safety and tolerability of once monthly aripiprazole treatment initiation in adults with schizophrenia stabilized on selected atypical oral antipsychotics other than aripiprazole. Curr Med Res Opin. 2013 Oct;29(10):1241-51. doi: 10.1185/03007995.2013.821973. Epub 2013 Jul 25.