Bipolar Disorder
Conditions
Keywords
bipolar disorder
Brief summary
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.
Detailed description
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.
Interventions
DRUGAripiprazole
Addressed in arm description.
DRUGPlacebo
Addressed in arm description.
Sponsors
Bristol-Myers Squibb
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Outpatients ages 5-17 years (inclusive) * Patients, who in the investigator's opinion have substantial symptoms of mania, depression, or both within the past 2 weeks such that treatment with a pharmacological agent is warranted * Currently meets Diagnostic Statistical Manual of Mental Disorders (DSM-IV) criteria for either cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment, Present and Lifetime Version (K-SADS-Present and Lifetime (PL) supplemented with sections from the Washington University K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist. * Offspring of a parent with a bipolar spectrum disorder (based on the results of either the Mini International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998) or the Family History Method (FH-RDC)(Andreasen et al., 1977) * Has another first or second degree relative with a mood disorder determined by the results of either the MINI or the FH-RDC * Has participated in at least 4 sessions of psychotherapy specifically focused on the symptoms/management of pediatric mood disorder and continues to have clinically significant symptomatology
Exclusion criteria
* Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day * Patients who have experienced a manic episode with documented treatment with APZ monotherapy at a dose of 0.2 mg/kg/day * Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated * Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorder * Patients with clinical evidence of mental retardation * Patients who are known to be allergic or hypersensitive to aripiprazole * Patients who are unable to swallow pills/capsules * Patients for whom the need for hospitalization during the course of the study appears likely * Patients who have started a new psychotherapeutic intervention within less than 4 weeks of randomization * Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder * Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia) * Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment * Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants) * Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months * Has met DSM-IV criteria for drug/alcohol abuse or dependence within the past 6 months * Females who are currently pregnant or lactating * Sexually active females, who in the investigators' opinion are not using an adequate form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Young Mania Rating Scale (YMRS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's Depression Rating Scale-Revised (CDRS-R ) | 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. |
| CDRS-R Children's Depression Rating Scale-Revised | 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. |
| Children's Global Assessment Scale (CGAS) | 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. |
| Clinical Global Impressions Scale (CGI-Severity) | 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). |
| Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Placebo Randomized Phase Placebo: Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Open Label Extension (OLE) | Drowsiness; Jittery | 0 | 1 |
| Open Label Extension (OLE) | Lack of Efficacy | 1 | 0 |
| Open Label Extension (OLE) | Lost to Follow-up | 3 | 5 |
| Open Label Extension (OLE) | Weight Gain | 1 | 0 |
| Randomized Phase | Adverse Event | 2 | 1 |
| Randomized Phase | Emesis and enuresis | 0 | 1 |
| Randomized Phase | Lack of Efficacy | 8 | 18 |
| Randomized Phase | Oral/nasal twitching | 0 | 1 |
| Randomized Phase | Participant reported having a rash | 1 | 0 |
| Randomized Phase | Study nonadherence | 2 | 1 |
| Randomized Phase | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Abilify Randomized Phase | Placebo Randomized Phase | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 29 Participants | 59 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 30 participants | 29 participants | 59 participants |
| Sex: Female, Male Female | 10 Participants | 14 Participants | 24 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 0 / 22 | 0 / 21 |
| other Total, other adverse events | 24 / 31 | 13 / 31 | 10 / 22 | 13 / 21 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 22 | 0 / 21 |
Outcome results
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Young Mania Rating Scale (YMRS) | 24.8 Scores on a scale | Standard Deviation 6.8 |
| Placebo Randomized Phase | Young Mania Rating Scale (YMRS) | 21.6 Scores on a scale | Standard Deviation 6.1 |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Young Mania Rating Scale (YMRS) | 9.7 Scores on a scale | Standard Deviation 9.2 |
| Placebo Randomized Phase | Young Mania Rating Scale (YMRS) | 16.2 Scores on a scale | Standard Deviation 8.5 |
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.
Time frame: Open-Label Extension - 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Young Mania Rating Scale (YMRS) | 5.73 Scores on a scale | Standard Deviation 5.98 |
| Placebo Randomized Phase | Young Mania Rating Scale (YMRS) | 7.57 Scores on a scale | Standard Deviation 5.12 |
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.
Time frame: Open-Label Extension - 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 18.1 Scores on a scale | Standard Deviation 14 |
| Placebo Randomized Phase | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 28.1 Scores on a scale | Standard Deviation 12.8 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 32.4 units on a scale | Standard Deviation 12.4 |
| Placebo Randomized Phase | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 36.8 units on a scale | Standard Deviation 12.5 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 21.0 units on a scale | Standard Deviation 14.5 |
| Placebo Randomized Phase | Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV) | 32.1 units on a scale | Standard Deviation 14.3 |
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.
Time frame: Open-Label Extension - 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | CDRS-R Children's Depression Rating Scale-Revised | 21.5 Scores on a scale | Standard Deviation 5.48 |
| Placebo Randomized Phase | CDRS-R Children's Depression Rating Scale-Revised | 21.7 Scores on a scale | Standard Deviation 5.54 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | CDRS-R Children's Depression Rating Scale-Revised | 24.4 Scores on a scale | Standard Deviation 7.5 |
| Placebo Randomized Phase | CDRS-R Children's Depression Rating Scale-Revised | 25.9 Scores on a scale | Standard Deviation 8.5 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Children's Depression Rating Scale-Revised (CDRS-R ) | 33.7 Scores on a scale | Standard Deviation 11.2 |
| Placebo Randomized Phase | Children's Depression Rating Scale-Revised (CDRS-R ) | 30.3 Scores on a scale | Standard Deviation 10.4 |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Children's Global Assessment Scale (CGAS) | 56.1 Scores on a scale | Standard Deviation 6.7 |
| Placebo Randomized Phase | Children's Global Assessment Scale (CGAS) | 57.5 Scores on a scale | Standard Deviation 4.6 |
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Children's Global Assessment Scale (CGAS) | 67.1 Scores on a scale | Standard Deviation 11.2 |
| Placebo Randomized Phase | Children's Global Assessment Scale (CGAS) | 61.4 Scores on a scale | Standard Deviation 8.7 |
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.
Time frame: Open-Label Extension - 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Children's Global Assessment Scale (CGAS) | 71.47 Scores on a scale | Standard Deviation 8.49 |
| Placebo Randomized Phase | Children's Global Assessment Scale (CGAS) | 69.72 Scores on a scale | Standard Deviation 6.47 |
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).
Time frame: Open-Label Extension - 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Clinical Global Impressions Scale (CGI-Severity) | 1.85 Scores on a scale | Standard Deviation 0.875 |
| Placebo Randomized Phase | Clinical Global Impressions Scale (CGI-Severity) | 1.89 Scores on a scale | Standard Deviation 0.758 |
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).
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Clinical Global Impressions Scale (CGI-Severity) | 2.3 units on a scale | Standard Deviation 1.4 |
| Placebo Randomized Phase | Clinical Global Impressions Scale (CGI-Severity) | 3.0 units on a scale | Standard Deviation 1.1 |
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).
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abilify Randomized Phase | Clinical Global Impressions Scale (CGI-Severity) | 4.2 units on a scale | Standard Deviation 0.9 |
| Placebo Randomized Phase | Clinical Global Impressions Scale (CGI-Severity) | 3.8 units on a scale | Standard Deviation 0.8 |