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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.
This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.
This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole-Randomized Phase | Active Comparator | Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response. |
|
| Placebo-Randomized Phase | Placebo Comparator | Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Addressed in arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. | Baseline |
| Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. | 12 weeks |
| Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Depression Rating Scale-Revised (CDRS-R ) | The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Findling, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center - Walker Building | Cleveland | Ohio | 44106 | United States |
After screening and baseline assessments study participants were assigned to aripiprazole or placebo. Treatment was initiated at a dose of 0.1mg/kg/d. The dose could be increased by approximately 0.05 mg/kg/d at each study visit if patient experienced residual symptomology with no intolerable side effect to maximum dose 15mg/d.
Patients were recruited beginning 8/2004 with follow up interviews completed 5/2012. Families were recruited from an outpatient child/adolescent psychiatric research center and an adult mood disorders program at University Hospitals, Case Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole | Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response. |
| FG001 | Placebo | placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized Phase |
|
| ||||||||||||||||||||||||
| Open Label Extension (OLE) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abilify Randomized Phase | Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response. |
| BG001 | Placebo Randomized Phase |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abilify Randomized Phase | Abilify (aripiprazole): Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment | One case in the abilify group had a dosing reduction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Findling, MD, MBA, Director, Child and Adolescent Psychiatry | Johns Hopkins University School of Medicine | 410-614-3225 | rfindli1@jhmi.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| Placebo | Drug | Addressed in arm description. |
|
| Open-Label Extension - 6 weeks |
| Baseline |
| CDRS-R Children's Depression Rating Scale-Revised | The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. | 12 weeks |
| CDRS-R Children's Depression Rating Scale-Revised | The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. | Open-Label Extension - 6 weeks |
| Children's Global Assessment Scale (CGAS) | Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis. | Baseline |
| Children's Global Assessment Scale (CGAS) | Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis. | 12 weeks |
| Children's Global Assessment Scale (CGAS) | Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis. | Open-Label Extension - 6 weeks |
| Clinical Global Impressions Scale (CGI-Severity) | Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Baseline |
| Clinical Global Impressions Scale (CGI-Severity) | Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | 12 weeks |
| Clinical Global Impressions Scale (CGI-Severity) | Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Open-Label Extension - 6 weeks |
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. | Baseline |
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. | 12 weeks |
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. | Open-Label Extension - 6 weeks |
| Withdrawal by Subject |
|
| Adverse Event |
|
| Participant reported having a rash |
|
| Emesis and enuresis |
|
| Oral/nasal twitching |
|
| NOT COMPLETED |
|
|
Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Abilify (aripiprazole) : Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
| OG001 | Placebo Randomized Phase | Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. |
|
|
| Primary | Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
|
| Primary | Young Mania Rating Scale (YMRS) | The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania. | 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the YMRS and were available and included the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Open-Label Extension - 6 weeks |
|
|
|
| Secondary | Children's Depression Rating Scale-Revised (CDRS-R ) | The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline |
|
|
|
| Secondary | CDRS-R Children's Depression Rating Scale-Revised | The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
|
| Secondary | CDRS-R Children's Depression Rating Scale-Revised | The CDRS-R is a rating scale used to assess severity of depression and change in depressive symptoms in children and adolescents. The CDRS-R is a 17-item scale administered by clinician's in interviews with a child/parent(s). Each item is scored on a range of 1-5 or 1-7 with a total possible score of 17-113. A score greater or equal to 40 is indicative of depression and a score less than or equal to 28 is typically means few or no depressive symptoms. | 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CDRS-R and were available and included the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Open-Label Extension - 6 weeks |
|
|
|
| Secondary | Children's Global Assessment Scale (CGAS) | Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis. | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline |
|
|
|
| Secondary | Children's Global Assessment Scale (CGAS) | Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis. | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | 12 weeks |
|
|
|
| Secondary | Children's Global Assessment Scale (CGAS) | Children's Global Assessment Scale (CGAS) is a scale that clinicians use in order to rate the general emotional and behavioral functioning of children and adolescents under age 18. The scoring range is either 1 to 100. Youth with higher scores indicate better functioning with 91-100 "Doing very well" to 1-10 Extremely impaired. The score should be calculated separate from diagnosis, treatment or prognosis. | 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 19 of those 22 and 18 of those 21 completed the CGAS and were available and included the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Open-Label Extension - 6 weeks |
|
|
|
| Secondary | Clinical Global Impressions Scale (CGI-Severity) | Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Clinical Global Impressions Scale (CGI-Severity) | Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Clinical Global Impressions Scale (CGI-Severity) | Clinical Global Impressions Scale (CGI-Severity) is a physician-administered assessment designed to track progress over time on a wide range of psychiatric disorders. The CGI-Severity or CGI-S consists of one question about the extent of a patient's mental illness at the time of the assessment. Using a 7-point rating scale, clinicians rate the severity of mental illness based on an average of observed and reported symptoms, behavior and function during the past 7 days. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 18 of those 21 completed the CGI-S and were available and included the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Open-Label Extension - 6 weeks |
|
|
|
| Secondary | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. | There were 30 patients in the Abilify group and 29 patients in the placebo group who completed at least 1 week of the study as per the participant flow. As a result of missing data, data on 28 of 30 in the Abilify group and 28 of 29 in the placebo group were available and included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | The Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) is a clinician-scored rating scale used to track the frequency of ADHD symptoms during the previous 1-week period. The ARS-IV contains 18 questions--(9 focused on inattention, and 9 on hyperactivity-impulsivity.) Questions are answered in a way that best describes ADHD symptom frequency--Never or Rarely=0, Sometimes=1, Often=2, or Very Often=3. The clinician adds up the responses for a total score. Higher total scores indicate a greater degree of symptoms being present. As a result, the minimum score is 0, and the maximum score is 54. | 22 patients in the Open-Label Extension (from initial Abilify) group and 21 patients in the Open-Label Extension (from initial placebo) group completed at least 1 week of the open-label extension (see participant flow). Due to missing data, data on 20 of those 22 and 17 of those 21 completed the ARS-IV and were available and included the analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Open-Label Extension - 6 weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 24 |
| 31 |
| EG001 | Placebo Randomized Phase | Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. | 0 | 31 | 0 | 31 | 13 | 31 |
| EG002 | Open Label Extension (Abilify) | Previously randomized to Abilify group. | 0 | 22 | 0 | 22 | 10 | 22 |
| EG003 | Open Label Extension (Placebo) | Previously randomized to placebo group. | 0 | 21 | 0 | 21 | 13 | 21 |
|
| Stomach ache | Gastrointestinal disorders | Systematic Assessment | One case in the abilify group had a dosing reduction |
|
| Sedation | General disorders | Systematic Assessment | One case in the placebo group had a dosing reduction |
|
| Increased appetite | General disorders | Systematic Assessment | Per study protocol as previously outlined |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Knee Pain, back ache |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Nasal Congestion | General disorders | Systematic Assessment |
|
| Coughing | General disorders | Systematic Assessment |
|
| Sore Throat | General disorders | Systematic Assessment |
|
| Cold Symptoms | General disorders | Systematic Assessment | Runny nose, Sneezing |
|
| Weight Gain | General disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Sinus infection |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Broken leg, broken nose, heel injury |
|
| Athletes Foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment | Tired, Tiredness, Fatigue, Going to bed early |
|
| Allergies | General disorders | Systematic Assessment | including nickel allergy |
|
| Feeling Cold | General disorders | Systematic Assessment |
|
| Ear infection | Infections and infestations | Systematic Assessment |
|
| Enuresis | Renal and urinary disorders | Systematic Assessment |
|
| Nose bleed | General disorders | Systematic Assessment |
|
| Increased heart rate | Cardiac disorders | Systematic Assessment |
|
| Decreased appetite | General disorders | Systematic Assessment |
|
| Restlessness | General disorders | Systematic Assessment |
|
| Influenza | General disorders | Systematic Assessment | Flu |
|
| Other | General disorders | Systematic Assessment | Can't remember music |
|
Not provided
Not provided
Not provided
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |