Aripiprazole Once-monthly in Patients With Schizophrenia

Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01959035

Enrollment

Registered

2013-10-09

Start date

2013-10-31

Completion date

2015-03-31

Last updated

2017-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

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.

Interventions

DRUGAripiprazole once-monthly

400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Patients will be recruited among those who complete treatment with aripiprazole in Study 14724A / NCT01795547. Inclusion Criteria: * The patient is judged to potentially benefit from 24-week treatment with aripiprazole once-monthly according to the clinical opinion of the investigator. * The patient agrees to protocol-defined use of effective contraception.

Exclusion criteria

* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 14724A / NCT01795547. * The patient has a clinically significant unstable illness diagnosed during Study 14724A / NCT01795547. * The patient is at significant risk of harming himself/herself or others according to the investigator's judgement or according to Columbia-Suicide Severity Rating Scale (C-SSRS). * The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability or efficacy, or interfere with the conduct or interpretation of the study. * The patient has one or more clinical laboratory test values outside the reference range, based on the blood or urine samples taken during the conduct of Study 14724A / NCT01795547 that are, in the investigator's opinion, of potential risk to the patient's safety. * The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason. Other inclusion and

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	Up to 24 weeks and 4-week safety follow up	Number of treatment emergent adverse events (TEAEs).

Secondary

Measure	Time frame	Description
Change From Baseline to Week 24 in CGI-S Score	Baseline and Week 24	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).
Change From Baseline to Week 24 in QLS Total Score	Baseline and Week 24	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.
Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score	Baseline and Week 24	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
Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score	Baseline and Week 24	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
Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score	Baseline and Week 24	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.
Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score	Baseline and Week 24	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.
Change From Baseline to Week 24 in the TooL Total Score	Baseline and Week 24	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).
Change From Baseline to Week 24 in the WoRQ Total Score	Baseline and Week 24	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.
Change From Baseline to Week 24 in ASEX Total Score	Baseline and Week 24	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).
Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale	Week 24	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.
Change From Baseline to Week 24 in SWN-S Total Score	Baseline and Week 24	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.
Change From Baseline to Week 12 in CGI-S Score	Baseline and Week 12	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).
Change From Baseline to Week 12 in QLS Total Score	Baseline and Week 12	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.
Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score	Baseline and Week 12	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
Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score	Baseline and Week 12	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
Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score	Baseline and Week 12	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
Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score	Baseline and Week 12	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.
Change From Baseline to Week 12 in the TooL Total Score	Baseline and Week 12	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).
Change From Baseline to Week 12 in the WoRQ Total Score	Baseline and Week 12	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.
Change From Baseline to Week 12 in ASEX Total Score	Baseline and Week 12	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).
Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale	Week 12	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.
Change From Baseline to Week 12 in SWN-S Total Score	Baseline and Week 12	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Aripiprazole Once-monthly Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline	88
Total	88

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	5
Overall Study	Lost to Follow-up	1
Overall Study	Other (no primary reason given)	1
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Aripiprazole Once-monthly
Age, Continuous	43.4 years STANDARD_DEVIATION 10.9
Sex: Female, Male Female	36 Participants
Sex: Female, Male Male	52 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	6 / 88
serious Total, serious adverse events	3 / 88

Outcome results

Primary

Safety and Tolerability

Number of treatment emergent adverse events (TEAEs).

Time frame: Up to 24 weeks and 4-week safety follow up

Population: Safety data is based on all patients who received at least one dose of investigational medicinal product (IMP) in Study 14724B.

Arm	Measure	Value (NUMBER)
Aripiprazole Once-monthly	Safety and Tolerability	65 number of events

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for ASEX total score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Aripiprazole Once-monthly	Change From Baseline to Week 12 in ASEX Total Score	-0.74 units on a scale

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for CGI-S score was based on the 83 patients who had a measure for this outcome

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Aripiprazole Once-monthly	Change From Baseline to Week 12 in CGI-S Score	0.00 units on a scale

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for QLS total score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Aripiprazole Once-monthly	Change From Baseline to Week 12 in QLS Total Score	2.08 units on a scale

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for SWN-S total score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Aripiprazole Once-monthly	Change From Baseline to Week 12 in SWN-S Total Score	-1.57 units on a scale

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Common Objects and Activities' QLS domain score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole Once-monthly	Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score	0.10 units on a scale	Standard Deviation 1.16

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Instrumental Role' QLS domain score was based on the 81 patients who had a measure for this outcome

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole Once-monthly	Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score	0.02 units on a scale	Standard Deviation 2.53

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Interpersonal Relations' QLS domain score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole Once-monthly	Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score	0.67 units on a scale	Standard Deviation 4.83

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (MEAN)	Dispersion
Aripiprazole Once-monthly	Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score	0.73 units on a scale	Standard Deviation 4.31

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for TooL total score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Aripiprazole Once-monthly	Change From Baseline to Week 12 in the TooL Total Score	-0.16 units on a scale

Secondary

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

Population: Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for WoRQ total score was based on the 82 patients who had a measure for this outcome

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Aripiprazole Once-monthly	Change From Baseline to Week 12 in the WoRQ Total Score	-0.55 units on a scale

Secondary