Safety and Tolerability Trial of Aripiprazole IM Depot Treatment in Adult Subjects With Schizophrenia Stabilized on Oral Antipsychotics Other Than Aripiprazole

NCT01552772 | Completed Phase 1 Results

• 1 other identifier: 31-11-289
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 12

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.

Conditions

Schizophrenia

Keywords

Safety; Tolerability; Schizophrenia; Aripiprazole

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AE).

  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.

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

Secondary Outcomes (10)

• 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 Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.

  Baseline, Week 1, 2 and 4

• 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 OC Data.

  Baseline, Week 1, 2, 4 and Last visit (Day 28).

Study Arms (1)

Aripiprazole IM Depot

EXPERIMENTAL

Drug: Aripiprazole IM Depot

Interventions

Aripiprazole IM Depot DRUG

400 mg intramuscular injection of aripiprazole

Also known as: Abilify

Aripiprazole IM Depot

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Subjects who were considered treatment-resistant to antipsychotic medication. (Subjects needed to have shown a previous response to an antipsychotic medication other than clozapine.)
• Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
• Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (12)

South Coast Clinical Trials

Anaheim, California, 92804, United States

Location

Comprehensive Clinical Development

Cerritos, California, 90703, United States

Location

Collaborative Neuroscience Network

Garden Grove, California, 92845, United States

Location

South Coast Clinical Trials

Norwalk, California, 90650, United States

Location

CNRI-San Diego

San Diego, California, 92102, United States

Location

Neuropsychiatric Research Center of Orange County

Santa Ana, California, 92701, United States

Location

Comprehensive Clinical Development

Washington D.C., District of Columbia, 20016, United States

Location

Accurate Clinical Trials

Kissimmee, Florida, 34741, United States

Location

Compass Research, LLC

Orlando, Florida, 32806, United States

Location

St. Louis Clinical Trials

St Louis, Missouri, 63118, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

Pillar Clinical Research

Dallas, Texas, 75243, United States

Location

Related Publications (1)

• 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.

  PMID: 23822566 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Stacy Wu, MD

  Otsuka Pharmaceutical Development and Commercialization

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: March 13, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: October 10, 2014
• Results First Posted: September 9, 2014

Record last verified: 2014-10

Locations

US (12)