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Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia (ASPIRE)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole IM Depot
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 Aripiprazole, IM Depot, Schizophrenia, Intramuscular

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 and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
  • Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
  • Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247.
  • # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
  • Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.

Exclusion Criteria:

  • 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 with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
  • Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
  • Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
  • 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 with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.

Sites / Locations

  • Study Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Active Treatment of aripiprazole IM depot (300mg or 400mg)

Outcomes

Primary Outcome Measures

Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
"Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.

Secondary Outcome Measures

Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
"Impending relapse criteria" was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage.
Percentage of Participants Achieving Remission.
Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.
Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.
"Stable" was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here.
Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.
Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.
PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.
To assess CGI-S, the rater or physician will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 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 participants.
Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.
PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Mean Clinical Global Impression of Improvement (CGI-I) Score.
To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 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.
Percentage of Participants Who Discontinued Due to All Causes.
Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.

Full Information

First Posted
August 5, 2008
Last Updated
November 14, 2014
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators
Covance
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1. Study Identification

Unique Protocol Identification Number
NCT00731549
Brief Title
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
Acronym
ASPIRE
Official Title
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.
Detailed Description
This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies 246/247. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or 31-07-247). This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period. During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Aripiprazole, IM Depot, Schizophrenia, Intramuscular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1081 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active Treatment of aripiprazole IM depot (300mg or 400mg)
Intervention Type
Drug
Intervention Name(s)
Aripiprazole IM Depot
Other Intervention Name(s)
Oral Aripiprazole
Intervention Description
300mg or 400mg
Primary Outcome Measure Information:
Title
Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
Description
"Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.
Time Frame
Baseline to Week 52/Last visit
Secondary Outcome Measure Information:
Title
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Description
"Impending relapse criteria" was defined as meeting all the following criteria: 1) Clinical Global Impression of Improvement (CGI-I) ≥ 5 (minimally worse), AND an increase to score of >4 and absolute increase of ≥ 2 on the individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content); or an increase to score >4 and absolute increase of ≥ 4 on the combined 4 PANSS items on any of these PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content) OR 2) Hospitalization due to worsening of psychotic symptoms, but excluding hospitalization for psychosocial reasons, OR 3) CGI-SS score of 4 (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much worse) or 7 (very much worse) on Part 2, OR 4) Violent behavior resulting in clinically relevant self-injury, injury to another person, or property damage.
Time Frame
Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal)
Title
Percentage of Participants Achieving Remission.
Description
Remission is defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of six months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, and lack of spontaneity.
Time Frame
Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52
Title
Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.
Description
"Stable" was defined as meeting all of the following criteria: Outpatient status; PANSS total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at Week 28 is described here.
Time Frame
Baseline to Week 28
Title
Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.
Description
Participants who first time meet relapse criteria were considered as having an event at date of exacerbation of psychotic symptoms/impending relapse. Time to first event was calculated as the earliest date of meeting one of relapse criteria. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
Time Frame
Baseline to Week 52
Title
Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.
Description
PANSS total score (range 30-210) is the sum of the rating scores for 7 positive scale items, 7 negative scale items and 16 general psychopathology scale items from the PANSS scale. PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Time Frame
Baseline, Weeks 12, 24, 52 and last visit
Title
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.
Description
To assess CGI-S, the rater or physician will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 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 participants.
Time Frame
Baseline, Weeks 12, 24, 52 and last visit
Title
Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.
Description
PANSS positive subscale score (range 7-49) is the sum of the rating scores for the 7 positive scale items from the PANSS scale. Positive subscale consists of 7 positive symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). PANSS negative subscale score (range 7-49) is the sum of the rating scores for the 7 negative scale items from the PANSS scale. Negative subscale consists of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking). The severity of each scale is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Time Frame
Baseline, Weeks 12, 24, 52 and last visit
Title
Mean Clinical Global Impression of Improvement (CGI-I) Score.
Description
To assess CGI-I the rater or physician will rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses will be compared to the participants condition at baseline. Response choices include: 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
Weeks 2, 4, 12, 24, 52 and last visit
Title
Percentage of Participants Who Discontinued Due to All Causes.
Description
Participants who discontinued due to any cause were noted. Limited concurrent treatment with oral aripiprazole was permitted as rescue therapy.
Time Frame
Baseline to Week 52

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 and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures. Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent. Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/247. # Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication. Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales. Exclusion Criteria: 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 with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine. Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment. Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine. 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 with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85226
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
City
La Habra
State/Province
California
ZIP/Postal Code
90631
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80130
Country
United States
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32839
Country
United States
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46222
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14213
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
Holliswood
State/Province
New York
ZIP/Postal Code
11423
Country
United States
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14615
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43609
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73139
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614-1707
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
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
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1058AAJ
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1405BOA
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425AHQ
Country
Argentina
City
Cordoba, Cordoba
ZIP/Postal Code
X5009BIN
Country
Argentina
City
La Plata, Buenos Aires
Country
Argentina
City
Mendoza
ZIP/Postal Code
5500HYF
Country
Argentina
City
Dandenong
State/Province
Victoria
ZIP/Postal Code
3175
Country
Australia
City
Epping
State/Province
Victoria
ZIP/Postal Code
3076
Country
Australia
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6959
Country
Australia
City
Glenside, SA
ZIP/Postal Code
5063
Country
Australia
City
Melbourne
ZIP/Postal Code
VIC 3004
Country
Australia
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
City
Brugge
ZIP/Postal Code
8200
Country
Belgium
City
Bourgas
ZIP/Postal Code
8000
Country
Bulgaria
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
City
Pazardjik
ZIP/Postal Code
4400
Country
Bulgaria
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Radnevo
ZIP/Postal Code
6260
Country
Bulgaria
City
Rousse
ZIP/Postal Code
7003
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1632
Country
Bulgaria
City
Varna
ZIP/Postal Code
9001
Country
Bulgaria
City
Veliko Tarnovo
ZIP/Postal Code
5007
Country
Bulgaria
City
San Bernardo, Santiago
ZIP/Postal Code
8780000
Country
Chile
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
City
Santiago
ZIP/Postal Code
7510186
Country
Chile
City
Santiago
ZIP/Postal Code
7580307
Country
Chile
City
Santiago
ZIP/Postal Code
8330838
Country
Chile
City
Santiago
ZIP/Postal Code
8900085
Country
Chile
City
Santiago
Country
Chile
City
Zagreb
ZIP/Postal Code
10 090
Country
Croatia
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
City
Jamejala
ZIP/Postal Code
71024
Country
Estonia
City
Tallinn
ZIP/Postal Code
10614
Country
Estonia
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
City
Elancourt
ZIP/Postal Code
78990
Country
France
City
Rennes
ZIP/Postal Code
35703
Country
France
City
St. Nazaire
ZIP/Postal Code
44606
Country
France
City
Baja
ZIP/Postal Code
6500
Country
Hungary
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
City
Cegléd
ZIP/Postal Code
2700
Country
Hungary
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600003
Country
India
City
Kanpur
ZIP/Postal Code
208005
Country
India
City
Mangalore
ZIP/Postal Code
575018
Country
India
City
Pune
ZIP/Postal Code
411004
Country
India
City
Tirupati
ZIP/Postal Code
517507
Country
India
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
City
Deajeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
City
Joong-gu, Incheon
ZIP/Postal Code
400-700
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
City
Tanjong Rambutan
State/Province
Perak
ZIP/Postal Code
31250
Country
Malaysia
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50603
Country
Malaysia
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
City
Selangor
ZIP/Postal Code
43000
Country
Malaysia
City
Mexico
State/Province
DF
ZIP/Postal Code
6700
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64040
Country
Mexico
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
City
San Luis Potosí
ZIP/Postal Code
78218
Country
Mexico
City
Aalesund
ZIP/Postal Code
6018
Country
Norway
City
Klepp stasjon
ZIP/Postal Code
4353
Country
Norway
City
Bataan
State/Province
Central Luzon
ZIP/Postal Code
2105
Country
Philippines
City
Mandaluyong
State/Province
NCR
ZIP/Postal Code
1553
Country
Philippines
City
Quezon City
State/Province
NCR
ZIP/Postal Code
1104
Country
Philippines
City
Iloilo
State/Province
Western Visayas
ZIP/Postal Code
5000
Country
Philippines
City
Belchatow
ZIP/Postal Code
97-400
Country
Poland
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85096
Country
Poland
City
Choroszcz
ZIP/Postal Code
16-070
Country
Poland
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
City
Leszno
ZIP/Postal Code
64-100
Country
Poland
City
Pruszkow
ZIP/Postal Code
05-802
Country
Poland
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-227
Country
Poland
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
City
Arad
ZIP/Postal Code
310022
Country
Romania
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
City
Cluj-Napoca
ZIP/Postal Code
400012
Country
Romania
City
Craiova
ZIP/Postal Code
200620
Country
Romania
City
Oradea
ZIP/Postal Code
410154
Country
Romania
City
Pitesti
ZIP/Postal Code
110069
Country
Romania
City
Lipetsk
ZIP/Postal Code
398007
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603152
Country
Russian Federation
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
188357
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
City
Liptovsky Mikulas
ZIP/Postal Code
3101
Country
Slovakia
City
Presov
ZIP/Postal Code
8001
Country
Slovakia
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
City
Cape Town
State/Province
Western Province
ZIP/Postal Code
7530
Country
South Africa
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Barcelona
ZIP/Postal Code
8005
Country
Spain
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
City
Taipei
ZIP/Postal Code
11086
Country
Taiwan
City
Muang
State/Province
Chiangmai
ZIP/Postal Code
50100
Country
Thailand
City
Muang
State/Province
Chiangmai
ZIP/Postal Code
50200
Country
Thailand
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia

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