A Phase 3 interventional study of Aripiprazole and Placebo in Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-26.
Sponsored by University Hospitals Cleveland Medical Center · Phase 3, Interventional, and Treatment
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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's enrollment of 62 is close to the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
Drug: Aripiprazole
Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
Drug: Placebo
Addressed in arm description.
Also known as: Abilify
Addressed in arm description.
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.
Time frame: 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.
Time frame: 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.
Time frame: Open-Label Extension - 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Open-Label Extension - 6 weeks
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.
| Milestone | Aripiprazole | Placebo |
|---|---|---|
| Started | 31 | 31 |
| Received more than one dose | 30 | 29 |
| Completed | 15 | 6 |
| Not completed | 16 | 25 |
| Withdrew: Lack of efficacy | 8 | 18 |
| Withdrew: Study nonadherence | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Participant reported having a rash | 1 | 0 |
| Withdrew: Emesis and enuresis | 0 | 1 |
| Withdrew: Oral/nasal twitching | 0 | 1 |
| Milestone | Aripiprazole | Placebo |
|---|---|---|
| Started | 22 | 21 |
| Completed | 17 | 15 |
| Not completed | 5 | 6 |
| Withdrew: Weight gain | 1 | 0 |
| Withdrew: Drowsiness; jittery | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Lack of efficacy | 1 | 0 |
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.
| Scores on a scale | Abilify Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Young Mania Rating Scale (YMRS) | 24.8 ± 6.8 | 21.6 ± 6.1 |
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.
| Scores on a scale | Abilify Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Young Mania Rating Scale (YMRS) | 9.7 ± 9.2 | 16.2 ± 8.5 |
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.
| Scores on a scale | Open-Label Extension (Abilify) | Open-Label Extension (Placebo) |
|---|---|---|
| Young Mania Rating Scale (YMRS) | 5.73 ± 5.98 | 7.57 ± 5.12 |
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.
| Scores on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Children's Depression Rating Scale-Revised (CDRS-R ) | 33.7 ± 11.2 | 30.3 ± 10.4 |
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.
| Scores on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| CDRS-R Children's Depression Rating Scale-Revised | 24.4 ± 7.5 | 25.9 ± 8.5 |
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.
| Scores on a scale | Open-Label Extension (Abilify) | Open-Label Extension (Placebo) |
|---|---|---|
| CDRS-R Children's Depression Rating Scale-Revised | 21.5 ± 5.48 | 21.7 ± 5.54 |
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.
| Scores on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Children's Global Assessment Scale (CGAS) | 56.1 ± 6.7 | 57.5 ± 4.6 |
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.
| Scores on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Children's Global Assessment Scale (CGAS) | 67.1 ± 11.2 | 61.4 ± 8.7 |
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.
| Scores on a scale | Open-Label Extension (Abilify) | Open-Label Extension (Placebo) |
|---|---|---|
| Children's Global Assessment Scale (CGAS) | 71.47 ± 8.49 | 69.72 ± 6.47 |
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).
| units on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Clinical Global Impressions Scale (CGI-Severity) | 4.2 ± 0.9 | 3.8 ± 0.8 |
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).
| units on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Clinical Global Impressions Scale (CGI-Severity) | 2.3 ± 1.4 | 3.0 ± 1.1 |
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).
| Scores on a scale | Open-Label Extension (Abilify) | Open-Label Extension (Placebo) |
|---|---|---|
| Clinical Global Impressions Scale (CGI-Severity) | 1.85 ± .875 | 1.89 ± .758 |
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.
| units on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 32.4 ± 12.4 | 36.8 ± 12.5 |
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.
| units on a scale | Aripiprazole Randomized Phase | Placebo Randomized Phase |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 21.0 ± 14.5 | 32.1 ± 14.3 |
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.
| Scores on a scale | Open-Label Extension (Abilify) | Open-Label Extension (Placebo) |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 18.1 ± 14.0 | 28.1 ± 12.8 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abilify Randomized Phase | 0/31 (0%) | 0/31 (0%) | 24/31 (77.4%) |
| Placebo Randomized Phase | 0/31 (0%) | 0/31 (0%) | 13/31 (41.9%) |
| Open Label Extension (Abilify) | 0/22 (0%) | 0/22 (0%) | 10/22 (45.5%) |
| Open Label Extension (Placebo) | 0/21 (0%) | 0/21 (0%) | 13/21 (61.9%) |
| Event | Abilify Randomized Phase | Placebo Randomized Phase | Open Label Extension (Abilify) | Open Label Extension (Placebo) |
|---|---|---|---|---|
| DrowsinessGeneral disorders | 0/31 | 0/31 | 0/22 | 11/21 |
| HeadacheNervous system disorders | 15/31 | 12/31 | 8/22 | 5/21 |
| Increased appetiteGeneral disorders | 7/31 | 1/31 | 8/22 | 1/21 |
| Stomach acheGastrointestinal disorders | 11/31 | 7/31 | 3/22 | 6/21 |
| EmesisGastrointestinal disorders | 7/31 | 0/31 | 6/22 | 1/21 |
| InjuryMusculoskeletal and connective tissue disorders | 0/31 | 0/31 | 6/22 | 2/21 |
| AllergiesGeneral disorders | 0/31 | 0/31 | 0/22 | 5/21 |
| SedationGeneral disorders | 7/31 | 2/31 | 1/22 | 4/21 |
| AcneSkin and subcutaneous tissue disorders | 0/31 | 0/31 | 0/22 | 4/21 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 5/31 | 2/31 | 4/22 | 1/21 |
| Age, Categorical(Participants) | Abilify Randomized Phase | Placebo Randomized Phase | Total |
|---|---|---|---|
| <=18 years | 30 | 29 | 59 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Abilify Randomized Phase | Placebo Randomized Phase | Total |
|---|---|---|---|
| Female | 10 | 14 | 24 |
| Male | 20 | 15 | 35 |
| Region of Enrollment(participants) | Abilify Randomized Phase | Placebo Randomized Phase | Total |
|---|---|---|---|
| United States | 30 | 29 | 59 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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University Hospitals Cleveland Medical Center