University Hospitals Case Medical Center - Walker Building
Cleveland, Ohio, 44106, United States
NCT Number: NCT00194012
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.
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Notify Me5 year–17 year
All sexes
Interventional
Phase 3
Cleveland, Ohio, 44106, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Addressed in arm description.
Other names: Abilify
Addressed in arm description.
Time frame: Baseline
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.
Time frame: 12 weeks
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.
Time frame: Open-Label Extension - 6 weeks
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.
Time frame: Baseline
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.
Time frame: 12 weeks
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.
Time frame: Open-Label Extension - 6 weeks
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.
Time frame: Baseline
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.
Time frame: 12 weeks
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.
Time frame: Open-Label Extension - 6 weeks
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.
Time frame: Baseline
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).
Time frame: 12 weeks
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).
Time frame: Open-Label Extension - 6 weeks
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).
Time frame: Baseline
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.
Time frame: 12 weeks
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.
Time frame: Open-Label Extension - 6 weeks
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.
University Hospitals Cleveland Medical Center
Other
Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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