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Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia (ATTAIN 266)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aripiprazole
Aripiprazole
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 Adolescent, Schizophrenia

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening.
  • Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.
  • Subjects who are currently being treated with oral or depot antipsychotics other than clozapine.
  • Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia.
  • Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).
  • Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or subjects who were on a stimulant treatment for any period of time over the last one year prior to screening.
  • Subjects with any neurodevelopmental disorder, except Tourette's syndrome.
  • Subjects experiencing acute depressive symptoms within the past 30 days prior to screening.
  • Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
  • Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.
  • Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism or hyperthyroidism (unless the condition has been stabilized with medication for at least 90 days prior to entry into Phase 1 or Phase 2).
  • Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Phase 1

Phase 2

Phase 3

Arm Description

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or placebo

Outcomes

Primary Outcome Measures

Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.
The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.

Secondary Outcome Measures

Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.
Percentage of Responders in Each Treatment Group.
Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.
Percentage of Participants Who Had Achieved Remission.
Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.
Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.
Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.

Full Information

First Posted
June 22, 2010
Last Updated
April 1, 2015
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01149655
Brief Title
Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia
Acronym
ATTAIN 266
Official Title
A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 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
Yes

5. Study Description

Brief Summary
This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period. Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3. Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability. A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
252 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1
Arm Type
Experimental
Arm Description
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Arm Title
Phase 3
Arm Type
Placebo Comparator
Arm Description
Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or placebo
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Primary Outcome Measure Information:
Title
Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.
Description
The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.
Time Frame
Baseline to Week 52/End of Phase 3 visit.
Secondary Outcome Measure Information:
Title
Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.
Description
Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.
Time Frame
Baseline to Week 52/End of Phase 3 visit.
Title
Percentage of Responders in Each Treatment Group.
Description
Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.
Time Frame
Baseline to Week 52/End of Phase 3 visit
Title
Percentage of Participants Who Had Achieved Remission.
Description
Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.
Time Frame
Baseline to Week 52/End of Phase 3 visit.
Title
Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.
Description
Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.
Time Frame
Baseline to Week 52/End of Phase 3 visit
Other Pre-specified Outcome Measures:
Title
Mean Change From Baseline to Endpoint in PANSS Total Score.
Description
The PANSS consisted of 3 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 were positive subscale, negative subscale and general psychopathology subscale. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame
Baseline to Week 52/End of Phase 3 visit.
Title
Mean Change From Baseline to Endpoint in CGI-S Score.
Description
The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-s, the Investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices included: 0= not assessed; 1= normal, not at all ill; 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 to Week 52/End of Phase 3 visit.
Title
Mean CGI-I Score at Endpoint.
Description
Baseline for the double-blind maintenance phase was defined as the last visit with available data in the stabilization phase, and the CGI-I scale was completed prior to or on the first dose date in the double-blind maintenance phase. 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
Baseline to Week 52/End of Phase 3 visit.
Title
Mean Change From Baseline to Endpoint in PANSS Positive Subscale.
Description
The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 positive symptom constructs were delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame
Baseline to Week 52/End of Phase 3 visit.
Title
Mean Change From Baseline to Endpoint in PANSS Negative Subscale.
Description
The PANSS consisted of 3 subscales were a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated (absence of symptoms) and a score of 7 indicated (extremely severe symptoms). The 7 negative symptom constructs were blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. The PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time Frame
Baseline to Week 52/End of Phase 3 visit.
Title
Mean Change From Baseline to Endpoint in Children's Global Assessment Scale (CGAS).
Description
The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS is a rating scale for evaluating the overall functioning of a participant during a specified time period on a continuum from psychological or psychiatric sickness to health. The CGAS is a valid and reliable tool for rating a child's general level of functioning on a health-illness continuum. CGAS score (range 1-100) was a single item score for rating a child's general level of functioning on a health-illness continuum, with higher scores represented better functioning.
Time Frame
Baseline to Week 52/End of Phase 3 visit.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening. Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics. Subjects who are currently being treated with oral or depot antipsychotics other than clozapine. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment. Exclusion Criteria: Subjects with a current DSM-IV-TR diagnosis other than schizophrenia. Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.). Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or subjects who were on a stimulant treatment for any period of time over the last one year prior to screening. Subjects with any neurodevelopmental disorder, except Tourette's syndrome. Subjects experiencing acute depressive symptoms within the past 30 days prior to screening. Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening. Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions. Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism or hyperthyroidism (unless the condition has been stabilized with medication for at least 90 days prior to entry into Phase 1 or Phase 2). Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Kohegyi, MD
Organizational Affiliation
Otsuka Pharmaceutical Development and Commercialization, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Study Site
City
Downy
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Study Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Study Site
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Study Site
City
Bloomfield Hills
State/Province
Michigan
ZIP/Postal Code
48302
Country
United States
Facility Name
Study Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Study Site
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Study Site
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Facility Name
Study Site
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530017
Country
India
Facility Name
Study Site
City
Raipur
State/Province
Chhattisgarh
ZIP/Postal Code
492001
Country
India
Facility Name
Study Site
City
Maninagar, Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380008
Country
India
Facility Name
Study Site
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431005
Country
India
Facility Name
Study Site
City
Wardha
State/Province
Maharastra
ZIP/Postal Code
442004
Country
India
Facility Name
Study Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600003
Country
India
Facility Name
Study Site
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
Study Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Study Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Facility Name
Study Site
City
Guntur
ZIP/Postal Code
522001
Country
India
Facility Name
Study Site
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
Study Site
City
Batu Caves
State/Province
Selangor darul Ehsan
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Study Site
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Study Site
City
Johor
ZIP/Postal Code
81200
Country
Malaysia
Facility Name
Study Site
City
Dasmarinas City
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Study Site
City
Bajada
State/Province
Davao City
ZIP/Postal Code
8000
Country
Philippines
Facility Name
Study Site
City
Manila City
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Study Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Study Site
City
Mandaluyong City
ZIP/Postal Code
1553
Country
Philippines
Facility Name
Study Site
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400084
Country
Romania
Facility Name
Study Site
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200620
Country
Romania
Facility Name
Study Site
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300239
Country
Romania
Facility Name
Study Site
City
Bucharest
ZIP/Postal Code
041914
Country
Romania
Facility Name
Study Site
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Study Site
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
Study Site
City
Ekaterinburg
ZIP/Postal Code
620030
Country
Russian Federation
Facility Name
Study Site
City
Kazan
ZIP/Postal Code
420061
Country
Russian Federation
Facility Name
Study Site
City
Lipetsk
ZIP/Postal Code
399313
Country
Russian Federation
Facility Name
Study Site
City
Moscow
ZIP/Postal Code
124617
Country
Russian Federation
Facility Name
Study Site
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
Study Site
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Study Site
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Study Site
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Facility Name
Study Site
City
Petrozavodsk
ZIP/Postal Code
185001
Country
Russian Federation
Facility Name
Study Site
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Study Site
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Study Site
City
St. Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Study Site
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
Study Site
City
Tonnelnyi Township
ZIP/Postal Code
357034
Country
Russian Federation
Facility Name
Study Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Study Site
City
Kaohsiung County
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Study Site
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Study Site
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28838583
Citation
Correll CU, Kohegyi E, Zhao C, Baker RA, McQuade R, Salzman PM, Sanchez R, Nyilas M, Carson W. Oral Aripiprazole as Maintenance Treatment in Adolescent Schizophrenia: Results From a 52-Week, Randomized, Placebo-Controlled Withdrawal Study. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):784-792. doi: 10.1016/j.jaac.2017.06.013. Epub 2017 Jul 8.
Results Reference
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Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

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