Aripiprazole, Abilify Maintena Collaborative Clinical Protocol

NCT02717130 | Terminated Results

• 1 other identifier: 031-104-0014
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

Brief Summary

An Open-label, Multi-center, Longitudinal, Within-subject Comparison Study to Evaluate the Effects of Aripiprazole Once Monthly in Subjects with Schizophrenia on 30-, 90-, and 180- day Re-hospitalization Rates Following Hospital Discharge Compared with Retrospective Re-hospitalization Rates while on Oral Antipsychotic Medication.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Assessment of Hospital Re-admission in a 30 Day Time Frame

  Psychiatric re-hospitalization were planning to be assessed using hospital admission records. Study stopped due to lack of enrollment.

  30 days

Study Arms (1)

Aripiprazole (Abilify Maintena)

EXPERIMENTAL

Aripiprazole once monthly (300-400 mg for entire study duration) plus 14 days oral antipsychotic medication (first injection only) (dosage according to package inserts). After the 14 day oral lead-in, after the first injection of aripiprazole once monthly, only oral aripiprazole will be allowed as a rescue medication.

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Aripiprazole (Abilify Maintena)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are able to provide written informed consent.
• Are male and female subjects 18 to 65 years of age, inclusive, at time of informed consent
• Have a current diagnosis of schizophrenia as defined by DSM-5 criteria and a history of the illness for at least 6 months prior to screening from a reliable source (e.g., subject, family member, friend, caregiver, healthcare provider, or medical records)
• Present at one of the selected inpatient units with acute psychotic symptoms for hospitalization at study entry
• Have a clinically indicated need for a change in current antipsychotic therapy
• Are on Medicaid with searchable claims data
• Have at least one inpatient psychiatric hospitalization or psychiatric ED visit within the 6 months prior to screening
• Have been previously prescribed oral antipsychotic treatment for the 6 consecutive months prior to screening
• Have a history of response to antipsychotic treatment, with no history of clozapine treatment
• Are able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, aripiprazole once monthly injection, and discontinuation of prohibited concomitant medications
• Are able to read and understand the written word in order to complete subject-reported outcomes measures
• Are willing to accept a monthly injection
• Are male and female subjects who are surgically sterile (i.e., have undergone orchiectomy or hysterectomy, respectively); female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to use an approved form of birth control during study participation

You may not qualify if:

• Has a current DSM-5 diagnosis other than schizophrenia, including schizophreniform disorder, schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also excluded are subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Prisoners or subjects who are involuntarily incarcerated, or have been incarcerated in the past 7 months for any reason
• Require potent cytochrome P450 (CYP)2D or CYP3A4 inhibitors or CYP3A4 inducers
• Are allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones or has a history of hypersensitivity to antipsychotic agents
• Have received electroconvulsive therapy within the 6 months prior to screening
• Have a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator
• Have current diagnosis of diabetes or known fasting triglyceride levels consistent with risk for pancreatitis
• Meets DSM-5 criteria for current substance use disorder within 3 months prior to screening
• Received treatment with long-acting injectable antipsychotics (e.g., haloperidol decanoate, fluphenazine decanoate, risperidone long-acting injection \[Risperdal Consta®\], paliperidone palmitate extended-release injectable suspension \[Invega® Sustenna®\], olanzapine for extended-release injectable suspension \[Zyprexa® Relprevv™\]), in which the last dose was within 7 months prior to screening
• Have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on Question 4 or Question 5 within the last 30 days on the baseline version of the C-SSRS
• Have a history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or efficacy during the course of the study, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the investigator
• Have been previously enrolled in an aripiprazole once monthly clinical study
• Have participated in any clinical study with an investigational agent within the past 30 days
• Are pregnant or lactating

Sponsors & Collaborators

• Florida Atlantic University: lead
• Washington University School of Medicine: collaborator
• University of Missouri-Columbia: collaborator
• University of Missouri, Kansas City: collaborator
• Burrell Behavioral Health: collaborator

Study Sites (4)

University of Missouri

Columbia, Missouri, 65211, United States

Location

University of Missouri

Kansas City, Missouri, 64108, United States

Location

Burrell Behavioral Health

Springfield, Missouri, 65804, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (18)

• Covell NH, Jackson CT, Evans AC, Essock SM. Antipsychotic prescribing practices in Connecticut's public mental health system: rates of changing medications and prescribing styles. Schizophr Bull. 2002;28(1):17-29. doi: 10.1093/oxfordjournals.schbul.a006920.

  PMID: 12047017 BACKGROUND

• Jablensky A, McGrath J, Herrman H, Castle D, Gureje O, Evans M, Carr V, Morgan V, Korten A, Harvey C. Psychotic disorders in urban areas: an overview of the Study on Low Prevalence Disorders. Aust N Z J Psychiatry. 2000 Apr;34(2):221-36. doi: 10.1080/j.1440-1614.2000.00728.x.

  PMID: 10789527 BACKGROUND

• Barnes TR, Shingleton-Smith A, Paton C. Antipsychotic long-acting injections: prescribing practice in the UK. Br J Psychiatry Suppl. 2009 Nov;52:S37-42. doi: 10.1192/bjp.195.52.s37.

  PMID: 19880915 BACKGROUND

• Barnes TR, Paton C, Hancock E, Cavanagh MR, Taylor D, Lelliott P; UK Prescribing Observatory for Mental Health. Screening for the metabolic syndrome in community psychiatric patients prescribed antipsychotics: a quality improvement programme. Acta Psychiatr Scand. 2008 Jul;118(1):26-33. doi: 10.1111/j.1600-0447.2008.01203.x.

  PMID: 18582345 BACKGROUND

• Coldham EL, Addington J, Addington D. Medication adherence of individuals with a first episode of psychosis. Acta Psychiatr Scand. 2002 Oct;106(4):286-90. doi: 10.1034/j.1600-0447.2002.02437.x.

  PMID: 12225495 BACKGROUND

• Verdoux H, Lengronne J, Liraud F, Gonzales B, Assens F, Abalan F, van Os J. Medication adherence in psychosis: predictors and impact on outcome. A 2-year follow-up of first-admitted subjects. Acta Psychiatr Scand. 2000 Sep;102(3):203-10. doi: 10.1034/j.1600-0447.2000.102003203.x.

  PMID: 11008856 BACKGROUND

• Leucht S, Heres S. Epidemiology, clinical consequences, and psychosocial treatment of nonadherence in schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:3-8.

  PMID: 16822090 BACKGROUND

• Thornicroft G, Farrelly S, Szmukler G, Birchwood M, Waheed W, Flach C, Barrett B, Byford S, Henderson C, Sutherby K, Lester H, Rose D, Dunn G, Leese M, Marshall M. Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial. Lancet. 2013 May 11;381(9878):1634-41. doi: 10.1016/S0140-6736(13)60105-1. Epub 2013 Mar 26.

  PMID: 23537606 BACKGROUND

• Burns T, Rugkasa J, Molodynski A, Dawson J, Yeeles K, Vazquez-Montes M, Voysey M, Sinclair J, Priebe S. Community treatment orders for patients with psychosis (OCTET): a randomised controlled trial. Lancet. 2013 May 11;381(9878):1627-33. doi: 10.1016/S0140-6736(13)60107-5. Epub 2013 Mar 26.

  PMID: 23537605 BACKGROUND

• Gaebel W, Schreiner A, Bergmans P, de Arce R, Rouillon F, Cordes J, Eriksson L, Smeraldi E. Relapse prevention in schizophrenia and schizoaffective disorder with risperidone long-acting injectable vs quetiapine: results of a long-term, open-label, randomized clinical trial. Neuropsychopharmacology. 2010 Nov;35(12):2367-77. doi: 10.1038/npp.2010.111. Epub 2010 Aug 4.

  PMID: 20686456 BACKGROUND

• Olivares JM, Rodriguez-Martinez A, Buron JA, Alonso-Escolano D, Rodriguez-Morales A; e-STAR Study Group. Cost-effectiveness analysis of switching antipsychotic medication to long-acting injectable risperidone in patients with schizophrenia : a 12- and 24-month follow-up from the e-STAR database in Spain. Appl Health Econ Health Policy. 2008;6(1):41-53. doi: 10.2165/00148365-200806010-00004.

  PMID: 18774869 BACKGROUND

• Kane JM, Carson WH, Saha AR, McQuade RD, Ingenito GG, Zimbroff DL, Ali MW. Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry. 2002 Sep;63(9):763-71. doi: 10.4088/jcp.v63n0903.

  PMID: 12363115 BACKGROUND

• Potkin SG, Saha AR, Kujawa MJ, Carson WH, Ali M, Stock E, Stringfellow J, Ingenito G, Marder SR. Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry. 2003 Jul;60(7):681-90. doi: 10.1001/archpsyc.60.7.681.

  PMID: 12860772 BACKGROUND

• Kasper S, Lerman MN, McQuade RD, Saha A, Carson WH, Ali M, Archibald D, Ingenito G, Marcus R, Pigott T. Efficacy and safety of aripiprazole vs. haloperidol for long-term maintenance treatment following acute relapse of schizophrenia. Int J Neuropsychopharmacol. 2003 Dec;6(4):325-37. doi: 10.1017/S1461145703003651.

  PMID: 14609439 BACKGROUND

• Kerwin R, Millet B, Herman E, Banki CM, Lublin H, Pans M, Hanssens L, L'Italien G, McQuade RD, Beuzen JN. A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients Schizophrenia Trial of Aripiprazole: (STAR) study. Eur Psychiatry. 2007 Oct;22(7):433-43. doi: 10.1016/j.eurpsy.2007.03.002. Epub 2007 Jun 7.

  PMID: 17555947 BACKGROUND

• Tandon R, Devellis RF, Han J, Li H, Frangou S, Dursun S, Beuzen JN, Carson W, Corey-Lisle PK, Falissard B, Jody DN, Kujawa MJ, L'italien G, Marcus RN, McQuade RD, Ray S, Van Peborgh P; IAQ Validation Study Group. Validation of the Investigator's Assessment Questionnaire, a new clinical tool for relative assessment of response to antipsychotics in patients with schizophrenia and schizoaffective disorder. Psychiatry Res. 2005 Sep 15;136(2-3):211-21. doi: 10.1016/j.psychres.2005.05.006.

  PMID: 16115690 BACKGROUND

• Vieta E, Bourin M, Sanchez R, Marcus R, Stock E, McQuade R, Carson W, Abou-Gharbia N, Swanink R, Iwamoto T; Aripoprazole Study Group. Effectiveness of aripiprazole v. haloperidol in acute bipolar mania: double-blind, randomised, comparative 12-week trial. Br J Psychiatry. 2005 Sep;187:235-42. doi: 10.1192/bjp.187.3.235.

  PMID: 16135860 BACKGROUND

• Schulte RF, Boesiger P. ProFit: two-dimensional prior-knowledge fitting of J-resolved spectra. NMR Biomed. 2006 Apr;19(2):255-63. doi: 10.1002/nbm.1026.

  PMID: 16541464 BACKGROUND

Related Links

• ACO #8-Risk Standardized All Condition Readmission
• Outcome Measures. Baltimore: Centers for Medicare \& Medicaid Services;
• Redmissions Reduction Program

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: John W. Newcomer, M.D., President & CEO
• Organization: Thriving Mind South Florida

jnewcomer@thrivingmind.org

305-860-0653

Study Officials

• John Newcomer, MD

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

• Ginger Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 23, 2016
• Study Start: June 8, 2016
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: April 13, 2020
• Results First Posted: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)