A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

Part A - Single Dose: Number of Participants with an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Time frame: Day 1 to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Number of Participants with an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Time frame: Day 1 to End of Trial (Maximum 169 Days from First Dose)

Part B: Number of Participants with an Adverse Event (AE)

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Time frame: Day 1 to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Number of Participants with Markedly Abnormal Vital Sign Measurements

Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Number of Participants with Markedly Abnormal Vital Sign Measurements

Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Number of Participants with Markedly Abnormal Vital Sign Measurements

Vital signs will be obtained prior to PK blood draws. Vital signs will include systolic and diastolic blood pressure, heart rate, and body temperature.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results

Standard 12-lead ECGs will be collected in triplicate (5 minutes apart). The ECGs will be collected prior to PK blood draws and after vital signs at the nominal time points, where applicable.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results

Standard 12-lead ECGs will be collected in triplicate (5 minutes apart). The ECGs will be collected prior to PK blood draws and after vital signs at the nominal time points, where applicable.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Number of Participants with Markedly Abnormal Electrocardiograms (ECGs) Results

Standard 12-lead ECGs will be collected in triplicate (5 minutes apart). The ECGs will be collected prior to PK blood draws and after vital signs at the nominal time points, where applicable.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Number of Participants with Markedly Abnormal Clinical Laboratory Results

Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Number of Participants with Markedly Abnormal Clinical Laboratory Results

Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Number of Participants with Markedly Abnormal Clinical Laboratory Results

Clinical Laboratory Monitoring includes serum chemistry, hematology and urinalysis.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Serum Prolactin

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Serum Prolactin

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Serum Prolactin

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Number of Participants with Markedly Abnormal Physical Examination Results

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Number of Participants with Markedly Abnormal Physical Examination Results

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Number of Participants with Markedly Abnormal Physical Examination Results

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception

VAS scores at Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29. The VAS is a test to assess injection site pain. Participants will be asked to give a score between 0-10 to rate pain, with 0 being no pain and 10 being worst possible pain.

Time frame: Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29

Part A - Multiple Dose: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception

VAS scores at 1-hour post-dose on Day 1, Day 29, Day 57, Day 85, Day 113. The VAS is a test to assess injection site pain. Participants will be asked to give a score between 0-10 to rate pain, with 0 being no pain and 10 being worst possible pain.

Time frame: 1-hour post-dose Day 1, Day 29, Day 57, Day 85, Day 113

Part B: Visual Analog Scale (VAS) Scores for Injection Site Pain Perception

VAS scores at Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29. The VAS is a test to assess injection site pain. Participants will be asked to give a score between 0-10 to rate pain, with 0 being no pain and 10 being worst possible pain.

Time frame: Day 1 immediately post-dose, 1 hour post-dose (+/- 15 minutes), Day 14 and Day 29

Part A - Single Dose: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Suicidality will be monitored throughout the trial using the C-SSRS (Columbia-Suicide Severity Rating Scale). This scale consists of a baseline evaluation that assesses the lifetime experience of the subject with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last assessment.The Baseline/Screening Version and the Since Last Visit version of the C-SSRS will be completed by trained trial site staff at each visit. A numerical score will correspond to one of ten categories relating to suicidal ideation and suicidal behavior. A higher score indicates a higher risk of suicidal behavior, but an answer of 'yes' to any question indicates some risk.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Suicidality will be monitored throughout the trial using the C-SSRS (Columbia-Suicide Severity Rating Scale). This scale consists of a baseline evaluation that assesses the lifetime experience of the subject with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last assessment.The Baseline/Screening Version and the Since Last Visit version of the C-SSRS will be completed by trained trial site staff at each visit. A numerical score will correspond to one of ten categories relating to suicidal ideation and suicidal behavior. A higher score indicates a higher risk of suicidal behavior, but an answer of 'yes' to any question indicates some risk.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline of Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Suicidality will be monitored throughout the trial using the C-SSRS (Columbia-Suicide Severity Rating Scale). This scale consists of a baseline evaluation that assesses the lifetime experience of the subject with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last assessment.The Baseline/ Screening Version and the Since Last Visit version of the C-SSRS will be completed by trained trial site staff at each visit. A numerical score will correspond to one of ten categories relating to suicidal ideation and suicidal behavior. A higher score indicates a higher risk of suicidal behavior, but an answer of 'yes' to any question indicates some risk.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Number of Injection Site Related Adverse Events

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.The injection site will be monitored by the investigator to assess the safety and tolerability of the drug.

Time frame: End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Number of Injection Site Related Adverse Events

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.The injection site will be monitored by the investigator to assess the safety and tolerability of the drug.

Time frame: End of Trial (Maximum 169 Days from First Dose)

Part B: Number of Injection Site Related Adverse Events

An AE is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.The injection site will be monitored by the investigator to assess the safety and tolerability of the drug.

Time frame: End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS)

EPS will be assessed using Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Rating Scale (BARS). The SAS consists of a list of 10 symptoms of Parkinsonism. Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms, and a score of 4 indicating a severe condition. The BARS consist of 4 items related to akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and 5 representing severe akathisia.

Time frame: Day 1 (predose) to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS)

EPS will be assessed using Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Rating Scale (BARS). The SAS consists of a list of 10 symptoms of Parkinsonism. Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms, and a score of 4 indicating a severe condition. The BARS consist of 4 items related to akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and 5 representing severe akathisia.

Time frame: Day 1 (predose) to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Assessment of Extrapyramidal Symptoms (EPS)

EPS will be assessed using Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Rating Scale (BARS). The SAS consists of a list of 10 symptoms of Parkinsonism. Each item will be rated on a 5-point scale, with a score of 1 representing absence of symptoms and a score of 5 representing a severe condition. The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item will be rated on a 5-point scale, with a score of 0 representing absence of symptoms, and a score of 4 indicating a severe condition. The BARS consist of 4 items related to akathisia. The first 3 items will be rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation will be made on a 6-point scale, with 0 representing absence of symptoms and 5 representing severe akathisia.

Time frame: Day 1 (predose) to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score

The PANSS will be administered using the Structured Clinical Interview-PANSS. The PANSS consists of 3 subscales containing a total of 30 symptom constructs.13 For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. This analysis will include participants with schizophrenia only.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score

The PANSS will be administered using the Structured Clinical Interview-PANSS. The PANSS consists of 3 subscales containing a total of 30 symptom constructs.13 For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. This analysis will include participants with schizophrenia only.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Positive and Negative Syndrome Scale Rating Criteria (PANSS) Score

The PANSS will be administered using the Structured Clinical Interview-PANSS. The PANSS consists of 3 subscales containing a total of 30 symptom constructs.13 For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. This analysis will include participants with schizophrenia only.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

The CGI-S Scale will be used to rate the severity of illness for each participant. The scale is a 7-point likert scale, where 1 indicates no illness and 7 indicates extremely ill.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

The CGI-S Scale will be used to rate the severity of illness for each participant. The scale is a 7-point likert scale, where 1 indicates no illness and 7 indicates extremely ill.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score

The CGI-S Scale will be used to rate the severity of illness for each participant. The scale is a 7-point likert scale, where 1 indicates no illness and 7 indicates extremely ill.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWN-S) Score

The subject's feeling of their own well-being will be assessed using the 20 question SWN-S. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items follow in random order. For items marked with a '+', response choices and scoring are as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWN-S) Score

The subject's feeling of their own well-being will be assessed using the 20 question SWN-S. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items follow in random order. For items marked with a '+', response choices and scoring are as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Subjective Well-being under Neuroleptic Treatment-Short Form (SWNS) Score

The subject's feeling of their own well-being will be assessed using the 20 question SWN-S. The questionnaire consists of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items follow in random order. For items marked with a '+', response choices and scoring are as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring is reversed; response choices and scoring are as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

The MADRS will be utilized as the primary assessment of a subject's level of depressive symptoms and must be administered using a structured interview guide. This scale consists of 10 items each with 7 defined grades of severity.This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

The MADRS will be utilized as the primary assessment of a subject's level of depressive symptoms and must be administered using a structured interview guide. This scale consists of 10 items each with 7 defined grades of severity.This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score

The MADRS will be utilized as the primary assessment of a subject's level of depressive symptoms and must be administered using a structured interview guide. This scale consists of 10 items each with 7 defined grades of severity. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Young Mania Rating Scale (YMRS) Score

The YMRS consists of 11 items assessing the core symptoms of mania and is based on the subject's subjective report of his or her clinical condition. Each item has 5 defined categories of severity with 4 items graded on a 0 to 8 scale (irritability, speech, content, and disruptive-aggressive behavior) and 7 items graded on a 0 to 4 scale. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Young Mania Rating Scale (YMRS) Score

The YMRS consists of 11 items assessing the core symptoms of mania and is based on the subject's subjective report of his or her clinical condition. Each item has 5 defined categories of severity with 4 items graded on a 0 to 8 scale (irritability, speech, content, and disruptive-aggressive behavior) and 7 items graded on a 0 to 4 scale. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Young Mania Rating Scale (YMRS) Score

The YMRS consists of 11 items assessing the core symptoms of mania and is based on the subject's subjective report of his or her clinical condition. Each item has 5 defined categories of severity with 4 items graded on a 0 to 8 scale (irritability, speech, content, and disruptive-aggressive behavior) and 7 items graded on a 0 to 4 scale. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)

Part A - Single Dose: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score

Severity of illness will be measured using the CGI-BP score. To assess CGI-S, the investigator will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the subject at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 126 Days from First Dose)

Part A - Multiple Dose: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score

Severity of illness will be measured using the CGI-BP score. To assess CGI-S, the investigator will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the subject at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 169 Days from First Dose)

Part B: Change from Baseline in Clinical Global Impression-Bipolar Version (CGI-BP) Score

Severity of illness will be measured using the CGI-BP score. To assess CGI-S, the investigator will answer the following question: "Considering your total clinical experience with this particular population, how mentally ill is the subject at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects. This analysis will include participants with bipolar only.

Time frame: Baseline to End of Trial (Maximum 57 Days from First Dose)