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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole (Abilify®) IM Depot Injection
Sponsored by
Otsuka Pharmaceutical Development & Commercialization, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPC-14597

Arm Description

Aripiprazole IM depot injection 300 mg or 400 mg.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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).
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.
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.

Full Information

First Posted
September 9, 2011
Last Updated
April 20, 2015
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01432444
Brief Title
Open-label Study to Compare Hospitalization Rates of Schizophrenic Patients Treated With Oral Antipsychotics Versus IM Depot Aripiprazole
Acronym
ARRIVE US
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
493 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC-14597
Arm Type
Experimental
Arm Description
Aripiprazole IM depot injection 300 mg or 400 mg.
Intervention Type
Drug
Intervention Name(s)
Aripiprazole (Abilify®) IM Depot Injection
Other Intervention Name(s)
ABILIFY®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).
Description
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).
Time Frame
Retrospective period Months 4-6; Prospective period Months 4-6
Secondary Outcome Measure Information:
Title
Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.
Description
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.
Time Frame
Baseline to Week 24
Title
Change From Baseline in PANSS Positive Subscale Score.
Description
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).
Time Frame
Baseline to Week 24
Title
Change From Baseline in PANSS Negative Subscale Score.
Description
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).
Time Frame
Baseline to Week 24
Title
Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).
Description
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.
Time Frame
Baseline to Week 24
Title
Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.
Description
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.
Time Frame
Week 4, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Cox, MD
Organizational Affiliation
Kevin.TC-Cox@otsuka-us.com
Official's Role
Study Director
Facility Information:
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
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United States
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Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
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United States
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Anaheim
State/Province
California
ZIP/Postal Code
92801
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United States
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Anaheim
State/Province
California
ZIP/Postal Code
92804
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United States
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Bellflower
State/Province
California
ZIP/Postal Code
90706
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United States
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Carson
State/Province
California
ZIP/Postal Code
90746
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United States
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Costa Mesa
State/Province
California
ZIP/Postal Code
92626
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United States
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
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Escondido
State/Province
California
ZIP/Postal Code
92025
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United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
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United States
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91206
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United States
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Los Angeles
State/Province
California
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
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United States
City
Norwalk
State/Province
California
ZIP/Postal Code
60950
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United States
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Oakland
State/Province
California
ZIP/Postal Code
94612
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United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
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United States
City
Orange
State/Province
California
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United States
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Palo Alto
State/Province
California
ZIP/Postal Code
94304
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United States
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Paramount
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California
ZIP/Postal Code
92626
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United States
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Pasadena
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California
ZIP/Postal Code
91106-2500
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United States
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Riverside
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California
ZIP/Postal Code
92506
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92108
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92117
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92121
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94104
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United States
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Santa Ana
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California
ZIP/Postal Code
92705
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United States
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Torrance
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California
ZIP/Postal Code
90502
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United States
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Middletown
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Connecticut
ZIP/Postal Code
06457
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United States
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New Brittain
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Connecticut
ZIP/Postal Code
06050
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United States
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Norwalk
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Connecticut
ZIP/Postal Code
06851
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United States
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Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
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United States
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Coral Gables
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Florida
ZIP/Postal Code
33134
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United States
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Doral
State/Province
Florida
ZIP/Postal Code
33172
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United States
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Hialeah
State/Province
Florida
ZIP/Postal Code
33014
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United States
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Jacksonville Beach
State/Province
Florida
ZIP/Postal Code
32250
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United States
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Miami
State/Province
Florida
ZIP/Postal Code
33122
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United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
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United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
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United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
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United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
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United States
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Oakland Park
State/Province
Florida
ZIP/Postal Code
33334
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United States
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Orange City
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Florida
ZIP/Postal Code
32763
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United States
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Orlando
State/Province
Florida
ZIP/Postal Code
32803
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United States
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Plantation
State/Province
Florida
ZIP/Postal Code
33317
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United States
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South Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
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St. Augustine
State/Province
Florida
ZIP/Postal Code
32086
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United States
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St. Petersburg
State/Province
Florida
ZIP/Postal Code
33716
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United States
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Tampa
State/Province
Florida
ZIP/Postal Code
33559
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United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
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United States
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30301
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United States
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Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-4296
Country
United States
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
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United States
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South Bend
State/Province
Indiana
ZIP/Postal Code
46617
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United States
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Topeka
State/Province
Kansas
ZIP/Postal Code
66606
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United States
City
Witchita
State/Province
Kansas
ZIP/Postal Code
67207
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United States
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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United States
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Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
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United States
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Newton
State/Province
Massachusetts
ZIP/Postal Code
02458
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United States
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Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
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United States
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Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
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United States
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Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
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United States
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Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
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United States
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
St. Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
City
Sparks
State/Province
Nevada
ZIP/Postal Code
89434
Country
United States
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11241
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14615
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
City
Wards Island
State/Province
New York
ZIP/Postal Code
10035
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Centennial
State/Province
Ohio
ZIP/Postal Code
80112
Country
United States
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
McMurray
State/Province
Pennsylvania
ZIP/Postal Code
15317
Country
United States
City
Phoenixville
State/Province
Pennsylvania
ZIP/Postal Code
19460
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8828
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Wharton
State/Province
Texas
ZIP/Postal Code
77488
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98033
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7M 5L9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27531181
Citation
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.
Results Reference
derived
PubMed Identifier
25347448
Citation
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.
Results Reference
derived
PubMed Identifier
23663091
Citation
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.
Results Reference
derived

Learn more about this trial

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

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