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Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. (ATTAIN 267)

Primary Purpose

Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Aripiprazole

About this trial

This is an interventional treatment trial for Adolescent Schizophrenia focused on measuring schizophrenia, adolescent, bipolar

Eligibility Criteria

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

Inclusion Criteria:

Subjects 13-17 years old (Schizophrenia); Subjects 10-17 years old (Bipolar manic or mixed episode)* [*Bulgaria will enroll Schizophrenia subjects only.]
Subjects with a current diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records).
Subjects with a current diagnosis of bipolar I disorder, manic or mixed episode with or without psychotic features (diagnosis or symptoms) experiencing symptoms for at least 1 week prior to screening. * [*These subjects will not be eligible to enroll in Bulgaria]
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 antipsychotics other than clozapine, and are not resistant to treatment with other antipsychotics.
Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2.

Exclusion Criteria:

All subjects: diagnosis of schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD.
Subjects with schizophrenia: a current major depressive episode.
Subjects with bipolar manic or mixed episode: presenting with a clinical picture and/or history that is consistent with a diagnosis of bipolar II disorder or bipolar disorder not otherwise specified.
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 any neurological disorder, with the exception of Tourette's syndrome.
Subjects experiencing major depressive episode at the time of screening other than subjects diagnosed with bipolar I disorder mixed episode.
Subjects who are currently receiving clozapine or have received clozapine at any time in the past are ineligible for entry into the study.
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 medications 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 (defined as fasting blood glucose ≥ 125 mg/dL).

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 1 and Phase 2

Arm Description

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

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant or participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. A treatment emergent adverse event (TEAE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study medication, whether or not considered to have a causal relationship with the study medication. A serious-AE or reaction was any untoward occurrence that, at any dose, was fatal, life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was any other medically significant event that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.

Secondary Outcome Measures

Incidence of Laboratory Values of Potential Clinical Relevance

The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.

Incidence of Physical Examination Findings of Potential Clinical Relevance

The physical examination evaluation was one of the parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.

Incidence of Vital Signs of Potential Clinical Relevance

Vital signs are taken at Baseline, Weeks 1, 2, 3, 4, 6, 8, and Months 3, 4, 6, 9, 12, 15, 18, 21, 24 of Phase 2 (Visits beyond Month 12 only for de novo subjects). Assessments included orthostatic (supine and standing) blood pressure (BP), heart rate and body temperature. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Abnormal vital signs in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.

Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)

The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.

Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score

The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.

Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score

The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).

Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)

The NY-AACENT is not a validated scale. It was included in this trial because of concerns that regulatory authorities (the European Committee for Medicinal Products for Human Use [CHMP] and the Paediatric Sub-Committee of the European Medicinal Agency [PDCO]) had regarding drug induced cognitive impairment. No validated scale addressing these issues was available at the time of the trial. The NY-AACENT was used to detect changes in cognitive function subsequent to pharmacological or similar treatments for neurological or psychiatric problems. It was specifically designed to be used in pediatric populations (ages 12 to 17), but could have been utilized with other age groups, as appropriate.

Baseline and Post-Baseline Tanner Staging

Tanner staging was completed together with the physical examination by the same trial-affiliated clinician in the most inconspicuous manner for the participant as possible. Tanner staging assessment consisted of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. A participant who reached Stage 5 (both in pubic hair and genitalia) did not need to continue with Tanner Staging assessment and the Tanner Staging scales of this participant were imputed as 5 for all of the following scheduled time points up to and including the completion visit/ET visit. The clinician arrived at a single score summarizing the domains (not individual domain scores) when evaluating the participant. The total shift data for last visit is presented below.

Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score

Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.

Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation

Percentage of Participants Who Discontinued Due to All Adverse Events

The percentage of participants who discontinued due to all causes other than sponsor terminating the trial was measured from the date of entering the open-label treatment phase to the date of ET for discontinued participants in the open-label treatment phase (ie, time to discontinuation = date of discontinuation [or date of completion for completed participants] - date of participant entering the open-label treatment phase + 1). If the participants completed the trial or were discontinued due to the sponsor terminating the trial, they were censored at the time of completion or trial termination, respectively.

Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

Mean Change From Baseline in PANSS Positive Subscale Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. 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).

Mean Change From Baseline in PANSS Negative Subscale Score

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic 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).

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

The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician 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 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 in Clinical Global Impression-Improvement (CGI-I) Score

The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's 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.

Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score

The YMRS consists of 11 items assessing the core symptoms of mania and was used to assess participants with bipolar I disorder, manic and mixed episodes with or without psychotic features: elevated mood, increased motor activity - energy, sexual interest, sleep, irritability, speech (rate and amount), language - thought disorder, content, disruptive - aggressive behavior, appearance, and insight. Each item had 5 or 9 grades of severity, with lower scores indicating milder symptoms. The number of raters within each trial center was to be kept to a minimum. The YMRS Total Score (range 0 to 44) is the sum of the rating scores for 11 items for assessing the core symptoms of mania. A missing value for any YMRS assessment item(s) could have resulted in a missing YMRS Total Score. A higher YMRS Total Score represents greater severity. In this study, 94 participants had bipolar disorder, this explains the N=94 in the table below and these were de novo participants.

Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score

The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Data for 94 de novo participants were available with bipolar disorder.

Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score

The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants.

Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale

The GBI is a self-report inventory with 73 items focusing on mood-related behaviors, including depressive, hypomanic, and biphasic symptoms. For this trial, two 20-item subscales were utilized: one was completed by the parent/guardian or legal representative, as applicable for local laws, and the other was completed by the participant. Responses were given on a 4-point Likert scale, with 0 being never or hardly ever and 3 being very often or almost constantly. The GBI Total Score for mania (range 0 to 30) is the sum of scores for items 1 to 10 and the GBI Total Score for depression (range 0 to 30) is the sum of scores for items 11 to 20 in the GBI Parent/Guardian or Subject Version panel. Scores from the Parent/Guardian and participant Versions were summarized separately. A missing value for any GBI assessment items could have resulted in a missing GBI Total Score. High scores represent greater psychopathology. Data was only available for 80 de novo participants with bipolar disorder.

Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score

The ADHD-RS-IV is a reliable and easy-to-administer instrument both for diagnosing ADHD in children and adolescents and for assessing treatment response. Containing 18 items, the scale was linked directly to DSM-IV-TR diagnostic criteria for ADHD. There were 3 versions of the scale: a parent questionnaire on home behaviors (English), a parent questionnaire on home behaviors (Spanish), and a teacher questionnaire on classroom behaviors. For this trial, the parent questionnaire on home behaviors (English) was utilized. The ADHD-RS-IV Total Score (range 0 to 54) is the sum of rating scores for 18 items, with higher scores representing greater severity. A missing value for any ADHD-RS-IV assessment items could have resulted in a missing ADHD-RS-IV Total Score. Data were only available for 82 participants with bipolar disorder and these were de novo participants.

Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)

The CGAS is a 100-point rating scale measuring psychological, social, and school functioning for children aged 6 to 17. It was adapted from the Adults Global Assessment Scale. The Global Assessment Scale was 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. The CGAS was developed by Schaffer and colleagues to provide a global measure of severity of disturbance in children and adolescents. The CGAS Score (range 1 to 100) is a single-item score for rating a child's general level of functioning on a health-illness continuum, with higher scores representing better functioning.

Full Information

NCT ID

NCT01122927

First Posted

May 6, 2010

Last Updated

January 8, 2016

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01122927

Brief Title

Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

Acronym

ATTAIN 267

Official Title

A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia or Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

The trial was terminated early as the objective of the Aripiprazole Pediatric Investigational Plan was met and provided 2 years of safety data.

Study Start Date

July 2010 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open-label study consisting of a screening period, a conversion/titration phase (Phase 1), an open-label treatment phase (Phase 2), and a follow-up period. The study will enroll new subjects (hereafter referred as "de novo" subjects) with schizophrenia, or bipolar I disorder, manic or mixed episode with or without psychotic features, and rollover subjects with schizophrenia from 31-09-266 (hereafter referred to as "Study 266"). All de novo subjects must enter the screening period of the study. Subjects who are screened and are not required to go through Phase 1 will complete a Phase 2 baseline visit prior to their participation in Phase 2. Study Design: Treatment, Single Group Assignment, Open Label, Active Control, Safety/Efficacy Study

6. Conditions and Keywords

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

Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Keywords

schizophrenia, adolescent, bipolar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

524 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 and Phase 2

Arm Type

Experimental

Arm 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 (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

Adverse events were recorded from the time of the informed consent was signed throughout the 24 month treatment period until the follow-up visit 30 (± 3) days after the end of trial.

Secondary Outcome Measure Information:

Title

Incidence of Laboratory Values of Potential Clinical Relevance

Description

Time Frame

Baseline to Month 24

Title

Incidence of Physical Examination Findings of Potential Clinical Relevance

Description

Time Frame

Baseline to Month 24

Title

Incidence of Vital Signs of Potential Clinical Relevance

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline by Week in Abnormal Involuntary Movement Scale (AIMS)

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline by Week in Simpson-Angus Scale (SAS) Total Score

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline by Week in Barnes Akathisia Rating Scale (BARS) Score

Description

Time Frame

Baseline to Month 24

Title

Number of Participants With Cognitive Impairment for Each New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT)

Description

Time Frame

Baseline to Month 24

Title

Baseline and Post-Baseline Tanner Staging

Description

Time Frame

Baseline to Last Visit

Title

Mean Change From Baseline for Columbia-Suicide Severity Rating Scale (C-SSRS) in Suicidal Ideation Intensity Total Score

Description

Time Frame

Baseline to Month 24

Title

Incidence of Suicidality, Suicidal Behavior and Suicidal Ideation

Description

Time Frame

Baseline to Month 24

Title

Percentage of Participants Who Discontinued Due to All Adverse Events

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in Positive and Negative Symptoms Score (PANSS) Total Score

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in PANSS Positive Subscale Score

Description

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. 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 Month 24

Title

Mean Change From Baseline in PANSS Negative Subscale Score

Description

The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic 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 Month 24

Title

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

Description

Time Frame

Baseline to Month 24

Title

Mean Change in Clinical Global Impression-Improvement (CGI-I) Score

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in Young Mania Rating Scale (YMRS) Score

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in Clinical Global Impression Scale - Bipolar (CGI-BP) Version Severity Score

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in Clinical Global Impression Scale - Bipolar Version Improvement Score

Description

The CGI-BP scale refers to the global impression of the subject with respect to bipolar disorder. The scale rated the subject's Severity of Illness (CGI-BP-Severity: mania, depression, and overall bipolar illness) and Change From Preceding Phase (CGI-BP-Improvement: mania, depression, and overall bipolar illness) based on a 7- or 8-point scale. Severity of Illness (CGI-BP-Severity) was rated at all visits. At each visit other than Day 0 (Baseline), the Change From Preceding Phase (CGI-BP-Improvement) was judged with respect to participant's condition at Baseline. The CGI-BP Severity Scores (range 1 to 7), as well as CGI-BP Improvement Scores (range 1 to 7) are single-item rating scores, with higher scores representing greater severity or less improvement. Only 94 participants had data at Baseline to explain the N=94 in the table below and these were de novo participants.

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in General Behavior Inventory (GBI) Scale Total Score for Mania and Depression in Both Parent/Guardian and Subject Version of the Scale

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in the Attention Deficit Hyperactive Disorders Rating (ADHD-RS-IV) Scale Score

Description

Time Frame

Baseline to Month 24

Title

Mean Change From Baseline in Children's Global Assessment Scale (CGAS) in Bipolar (de Novo Participants)

Description

Time Frame

Baseline to Month 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects 13-17 years old (Schizophrenia); Subjects 10-17 years old (Bipolar manic or mixed episode)* [*Bulgaria will enroll Schizophrenia subjects only.] Subjects with a current diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records). Subjects with a current diagnosis of bipolar I disorder, manic or mixed episode with or without psychotic features (diagnosis or symptoms) experiencing symptoms for at least 1 week prior to screening. * [*These subjects will not be eligible to enroll in Bulgaria] 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 antipsychotics other than clozapine, and are not resistant to treatment with other antipsychotics. Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2. Exclusion Criteria: All subjects: diagnosis of schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD. Subjects with schizophrenia: a current major depressive episode. Subjects with bipolar manic or mixed episode: presenting with a clinical picture and/or history that is consistent with a diagnosis of bipolar II disorder or bipolar disorder not otherwise specified. 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 any neurological disorder, with the exception of Tourette's syndrome. Subjects experiencing major depressive episode at the time of screening other than subjects diagnosed with bipolar I disorder mixed episode. Subjects who are currently receiving clozapine or have received clozapine at any time in the past are ineligible for entry into the study. 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 medications 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 (defined as fasting blood glucose ≥ 125 mg/dL).

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

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Study Site

City

Downey

State/Province

California

ZIP/Postal Code

90241

Country

United States

Facility Name

Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Study Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Study Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Study Site

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30080

Country

United States

Facility Name

Study Site

City

Oak Brook

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

Study Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Study Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

Study Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Study Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

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

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Study Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Study Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Study Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

Facility Name

Study Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Study Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Study Site

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77381

Country

United States

Facility Name

Study Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Study Site

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

Study Site

City

Bothell

State/Province

Washington

ZIP/Postal Code

98011

Country

United States

Facility Name

Study Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

Study Site

City

Bourgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Study Site

City

Pazardjik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Study Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Study Site

City

Rousse

ZIP/Postal Code

7004

Country

Bulgaria

Facility Name

Study Site 2

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Study Site

City

Targovishte

ZIP/Postal Code

7700

Country

Bulgaria

Facility Name

Study Site 1

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Study Site 2

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Study Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Study Site 1

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Study Site 2

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Study Site

City

Budapest

ZIP/Postal Code

H-1021

Country

Hungary

Facility Name

Study Site

City

Budapest

ZIP/Postal Code

H-1135

Country

Hungary

Facility Name

Study Site

City

Gyula

ZIP/Postal Code

H-5700

Country

Hungary

Facility Name

Study Site

City

Szeged

ZIP/Postal Code

H-6725

Country

Hungary

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

530002

Country

India

Facility Name

Study Site

City

Visakhapatnam

State/Province

Andhra Pradesh

ZIP/Postal Code

530017

Country

India

Facility Name

Study Site 1

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380006

Country

India

Facility Name

Study Site 2

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380006

Country

India

Facility Name

Study Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380013

Country

India

Facility Name

Study Site

City

Maninagar, Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380008

Country

India

Facility Name

Study Site

City

Mangalore

State/Province

Karnataka

ZIP/Postal Code

575001

Country

India

Facility Name

Study Site

City

Calicut

State/Province

Kerala

ZIP/Postal Code

673009

Country

India

Facility Name

Study Site

City

Nasik

State/Province

Maharashtra

ZIP/Postal Code

422101

Country

India

Facility Name

Study Site

City

Ludhiana

State/Province

Punjab

ZIP/Postal Code

141001

Country

India

Facility Name

Study Site

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302017

Country

India

Facility Name

Study Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600003

Country

India

Facility Name

Study Site

City

Maduri

State/Province

Tamil Nadu

ZIP/Postal Code

625020

Country

India

Facility Name

Study Site

City

Kanpur

State/Province

Uttar Pradesh

ZIP/Postal Code

208005

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

Kuala Lumpur

State/Province

Wilayah Persekutuan

ZIP/Postal Code

50603

Country

Malaysia

Facility Name

Study Site

City

Dasmarinas City

State/Province

Cavite

ZIP/Postal Code

4114

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

Białystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Study Site

City

Gdansk Wrzeszcz

ZIP/Postal Code

80-282

Country

Poland

Facility Name

Study Site

City

Toruń

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Study Site

City

Wrocław

ZIP/Postal Code

50-227

Country

Poland

Facility Name

Study Site

City

Wrocław

ZIP/Postal Code

54-235

Country

Poland

Facility Name

Study Site

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400084

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

Craiova, Dolj

ZIP/Postal Code

200620

Country

Romania

Facility Name

Study Site

City

Iasi

ZIP/Postal Code

700282

Country

Romania

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 region

ZIP/Postal Code

460551

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 1

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Study Site 2

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Study Site

City

Novi Sad

ZIP/Postal Code

21000

Country

Serbia

Facility Name

Study Site

City

Taipei City

ZIP/Postal Code

110

Country

Taiwan

Facility Name

Study Site

City

Dnepropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

Study Site

City

Donetsk

ZIP/Postal Code

83037

Country

Ukraine

Facility Name

Study Site 1

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Study Site 2

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

Study Site

City

Kherson

ZIP/Postal Code

73488

Country

Ukraine

Facility Name

Study Site

City

Lugansk

ZIP/Postal Code

91045

Country

Ukraine

Facility Name

Study Site

City

Lviv

ZIP/Postal Code

79021

Country

Ukraine

Facility Name

Study Site

City

Odessa

ZIP/Postal Code

65006

Country

Ukraine

Facility Name

Study Site

City

Simferopol Crimea

ZIP/Postal Code

95006

Country

Ukraine

Facility Name

Study Site

City

Temopil

ZIP/Postal Code

4620

Country

Ukraine

Facility Name

Study Site

City

Vinnytsya

ZIP/Postal Code

21005

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features.

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Safety and Tolerability of Aripiprazole in Adolescents With Schizophrenia or Children and Adolescents With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features. (ATTAIN 267)

Adolescent Schizophrenia, Child or Adolescent Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial