To obtain information on the safety, tolerability and effectiveness of aripiprazole once-monthly in a manner consistent with its intended use in everyday clinical practice in patients with schizophrenia who completed Study 14724A / NCT01795547.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
US006
San Diego, California, United States
Safety and Tolerability
Number of treatment emergent adverse events (TEAEs).
Time frame: Up to 24 weeks and 4-week safety follow up
Change From Baseline to Week 24 in SWN-S Total Score
The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in CGI-S Score
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in QLS Total Score
The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
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Time frame: Baseline and Week 24
Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in the TooL Total Score
Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in the WoRQ Total Score
The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in ASEX Total Score
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).
Time frame: Baseline and Week 24
Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.
Time frame: Week 24
Change From Baseline to Week 12 in SWN-S Total Score
The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in CGI-S Score
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in QLS Total Score
The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score
The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in the TooL Total Score
Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in the WoRQ Total Score
The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in ASEX Total Score
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction).
Time frame: Baseline and Week 12
Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale
The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, "How strong is your sex drive?", "Are your orgasms satisfying?") and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items.
Time frame: Week 12