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SchizophreniaPhase 3ARRIVE USNCT01432444

Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole

A Phase 3 study testing Aripiprazole (Abilify®) IM Depot Injection in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 124 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole (Abilify®) IM Depot Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
124 sitesin 2 countries
Study dates
Sep 2011to Dec 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who are able to provide written informed consent. If the IRB requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure.
  • Male and female subjects 18 to 65 years of age, inclusive.
  • Current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a history of the illness for at least 1 year (12 months).
  • Subjects who in the investigator's judgment would benefit from extended treatment with a long-acting injectable formulation.
  • Subjects who have at least 1 inpatient psychiatric hospitalization in the 4 years (48 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study.
  • Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase.
  • Subjects who have shown response to previous antipsychotic treatment.
  • Subjects who understand the nature of the trial and are able to follow the protocol requirements.

Who cannot join

  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial.
  • Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial.
  • Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication.
  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Subjects with a history of hypersensitivity to antipsychotic agents.
  • Subjects deemed intolerant of receiving injectable treatment.
Show all 21Show fewer
  • Subjects who have received electroconvulsive therapy within the last 7 months prior to screening.
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
  • 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 requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the ICF or during the screening period.
  • Subjects without at least 1 inpatient psychiatric hospitalization in the last 4 years (48 months) prior to screening.
  • Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening.
  • Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine.
  • Treatment with long-acting injectable antipsychotics in which the last dose was within 7 months prior to screening.
  • Subjects who have not been treated with oral antipsychotics for 7 months prior to screening.
  • Subjects who have a significant risk of committing suicide
  • Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial.
  • Females who are pregnant or lactating, sexually active males and females who will not commit to utilizing birth control during the trial and for up to 180 days following the trial.
  • Abnormal laboratory or physical examination results indicating a condition which may interfere with the results of the study or pose a safety risk to the subject.
  • Subjects who have previously enrolled in an aripiprazole IM depot clinical study, except for subjects entering this trial from the Canadian 31-11-284 trial.
  • Subjects who have participated in any clinical trial with an investigational agent within the past 30 days.

Trial locations and contacts

124 sites in 2 countries.

124 sites in 2 countries

United States119 sites

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Amherst, New York, 14226

  • Study site

    Anaheim, California, 92801

  • Study site

    Anaheim, California, 92804

  • Study site

    Atlanta, Georgia, 30301

  • Study site

    Austin, Texas, 78731

  • Study site

    Bellevue, Washington, 98007

  • Study site

    Bellflower, California, 90706

  • Study site

    Bloomfield Hills, Michigan, 48302

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Bothell, Washington, 98011

  • Study site

    Boynton Beach, Florida, 33435

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn, New York, 11206

  • Study site

    Brooklyn, New York, 11241

  • Study site

    Buffalo, New York, 14215

  • Study site

    Canton, Ohio, 44718

  • Study site

    Carson, California, 90746

  • Study site

    Centennial, Ohio, 80112

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chicago, Illinois, 60611-4296

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Creve Coeur, Missouri, 63141

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75390-8828

  • Study site

    Decatur, Georgia, 30030

  • Study site

    Doral, Florida, 33172

  • Study site

    Dothan, Alabama, 36305

  • Study site

    Downey, California, 90241

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Escondido, California, 92025

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Franklin, Tennessee, 37067

  • Study site

    Garden Grove, California, 92845

  • Study site

    Garfield Heights, Ohio, 44125

  • Study site

    Glendale, California, 91204

  • Study site

    Glendale, California, 91206

  • Study site

    Grand Rapids, Michigan, 49503

  • Study site

    Hialeah, Florida, 33014

  • Study site

    Houston, Texas, 77054

  • Study site

    Houston, Texas, 77081

  • Study site

    Jacksonville Beach, Florida, 32250

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Kansas City, Missouri, 64108

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Kirkland, Washington, 98033

  • Study site

    Lincoln, Nebraska, 68526

  • Study site

    Little Rock, Arkansas, 72201

  • Study site

    Los Angeles, California

  • Study site

    Marietta, Georgia, 30062

  • Study site

    Mason, Ohio, 45040

  • Study site

    McMurray, Pennsylvania, 15317

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Miami, Florida, 33122

  • Study site

    Miami, Florida, 33125

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami, Florida, 33155

  • Study site

    Middletown, Connecticut, 06457

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Minneapolis, Minnesota, 55454

  • Study site

    Naperville, Illinois, 60563

  • Study site

    Nashua, New Hampshire, 03060

  • Study site

    National City, California, 91950

  • Study site

    New Brittain, Connecticut, 06050

  • Study site

    New York, New York, 10027

  • Study site

    New York, New York, 10065

  • Study site

    New York, New York, 10128

  • Study site

    Newton, Massachusetts, 02458

  • Study site

    North Platte, Nebraska, 69101

  • Study site

    Norwalk, California, 60950

  • Study site

    Norwalk, Connecticut, 06851

  • Study site

    Oakland, California, 94612

  • Study site

    Oakland Park, Florida, 33334

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Orange City, Florida, 32763

  • Study site

    Orlando, Florida, 32803

  • Study site

    Palo Alto, California, 94304

  • Study site

    Paramount, California, 92626

  • Study site

    Pasadena, California, 91106-2500

  • Study site

    Paw Paw, Michigan, 49079

  • Study site

    Phoenixville, Pennsylvania, 19460

  • Study site

    Plantation, Florida, 33317

  • Study site

    Riverside, California, 92506

  • Study site

    Rochester, New York, 14615

  • Study site

    Rochester, New York, 14618

  • Study site

    Saint Augustine, Florida, 32086

  • Study site

    Saint Charles, Missouri, 63301

  • Study site

    Salt Lake City, Utah, 84105

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92117

  • Study site

    San Diego, California, 92121

  • Study site

    San Francisco, California, 94104

  • Study site

    Santa Ana, California, 92705

  • Study site

    Scranton, Pennsylvania, 18503

  • Study site

    Sellersville, Pennsylvania, 18960

  • Study site

    Sioux Falls, South Dakota, 57105

  • Study site

    South Bend, Indiana, 46617

  • Study site

    South Miami, Florida, 33143

  • Study site

    Sparks, Nevada, 89434

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St. Petersburg, Florida, 33716

  • Study site

    Syracuse, New York, 13202

  • Study site

    Tampa, Florida, 33559

  • Study site

    Tampa, Florida, 33613

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Torrance, California, 90502

  • Study site

    Tucson, Arizona, 85719

  • Study site

    Wards Island, New York, 10035

  • Study site

    Wharton, Texas, 77488

  • Study site

    Witchita, Kansas, 67207

Other trials in United States

Canada5 sites

  • Study site

    Brampton, Ontario, L6T 0G1

  • Study site

    Chatham, Ontario, N7M 5L9

  • Study site

    Halifax, Nova Scotia, B3H 2E2

  • Study site

    Montreal, Quebec, H3A1A1

  • Study site

    Penticton, British Columbia, V2A 4M4

Other trials in Canada

About this study

Official title: Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting

The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.

Read the detailed description

Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.

Conditions
Schizophrenia
Being tested
Aripiprazole (Abilify®) IM Depot Injection
Keywords
Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole (Abilify®) IM Depot InjectionDrug

    Also called ABILIFY®

    400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.

    Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.

Study groups in NCT01432444
Study groupRoleWhat they receive
OPC-14597ExperimentalAripiprazole IM depot injection 300 mg or 400 mg.
Receives: Drug: Aripiprazole (Abilify®) IM Depot Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).

    The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).

    Measured: Retrospective period Months 4-6; Prospective period Months 4-6

Secondary outcomes (5)

  1. Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.

    The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.

    Measured: Baseline to Week 24

  2. Change From Baseline in PANSS Positive Subscale Score.

    The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).

    Measured: Baseline to Week 24

  3. Change From Baseline in PANSS Negative Subscale Score.

    The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).

    Measured: Baseline to Week 24

  4. Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).

    The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.

    Measured: Baseline to Week 24

  5. Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.

    The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.

    Measured: Week 4, 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432444
Sponsor's protocol ID
31-11-283
Acronym
ARRIVE US
Status last verified
Apr 2015
First submitted
9 Sep 2011
Last updated
7 May 2015
Data monitoring committee
No

Publications

  • Peters-Strickland T, Zhao C, Perry PP, Eramo A, Salzman PM, McQuade RD, Johnson BR, Sanchez R. Effects of aripiprazole once-monthly on symptoms of schizophrenia in patients switched from oral antipsychotics. CNS Spectr. 2016 Dec;21(6):460-465. doi: 10.1017/S1092852916000365. Epub 2016 Aug 17.

    PubMed 27531181

  • Kane JM, Zhao C, Johnson BR, Baker RA, Eramo A, McQuade RD, Duca AR, Sanchez R, Peters-Strickland T. Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis. J Med Econ. 2015 Feb;18(2):145-54. doi: 10.3111/13696998.2014.979936. Epub 2014 Nov 10.

    PubMed 25347448

  • Kane JM, Sanchez R, Zhao J, Duca AR, Johnson BR, McQuade RD, Eramo A, Baker RA, Peters-Strickland T. Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia. J Med Econ. 2013 Jul;16(7):917-25. doi: 10.3111/13696998.2013.804411. Epub 2013 May 28.

    PubMed 23663091

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole (Abilify®) IM Depot Injection in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 124 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6). (time frame: Retrospective period Months 4-6; Prospective period Months 4-6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01432444, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.

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