Trial Outcomes & Findings for Aripiprazole Once-monthly in Patients With Schizophrenia (NCT NCT01959035)

NCT ID: NCT01959035

Last Updated: 2017-03-17

Results Overview

Number of treatment emergent adverse events (TEAEs).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 88 participants
• Primary outcome timeframe: Up to 24 weeks and 4-week safety follow up
• Results posted on: 2017-03-17

Participant Flow

Participant milestones

Measure	Aripiprazole Once-monthly Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
Overall Study STARTED	88
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Aripiprazole Once-monthly Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1
Overall Study Other (no primary reason given)	1

Baseline Characteristics

Aripiprazole Once-monthly in Patients With Schizophrenia

Baseline characteristics by cohort

Measure	Aripiprazole Once-monthly n=88 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Age, Continuous	43.4 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Number of treatment emergent adverse events (TEAEs).

Outcome measures

Measure	Aripiprazole Once-monthly n=88 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Safety and Tolerability	65 number of events

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for SWN-S total score was based on the 75 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=75 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in SWN-S Total Score	0.19 units on a scale Interval -2.08 to 2.45

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for CGI-S score was based on the 78 patients who had a measure for this outcome

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).

Outcome measures

Measure	Aripiprazole Once-monthly n=78 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in CGI-S Score	-0.10 units on a scale Interval -0.26 to 0.06

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for QLS total score was based on the 78 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=78 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in QLS Total Score	2.32 units on a scale Interval -1.21 to 5.85

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for 'Common Objects and Activities' QLS domain score was based 78 patients who had a measure for this outcome

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

Outcome measures

Measure	Aripiprazole Once-monthly n=78 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score	0.21 units on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 78 patients who had a measure for this outcome

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

Outcome measures

Measure	Aripiprazole Once-monthly n=78 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score	0.72 units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for 'Interpersonal Relations' QLS domain score was based on the 78 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=78 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score	0.58 units on a scale Standard Deviation 6.54

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for 'Instrumental Role' QLS domain score was based on the 78 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=78 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score	0.42 units on a scale Standard Deviation 4.54

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for TooL total score was based on the 75 patients who had a measure for this outcome

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).

Outcome measures

Measure	Aripiprazole Once-monthly n=75 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in the TooL Total Score	-0.47 units on a scale Interval -1.16 to 0.22

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for WoRQ total score was based on the 77 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=77 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in the WoRQ Total Score	-0.53 units on a scale Interval -1.21 to 0.15

SECONDARY outcome

Timeframe: Baseline and Week 24

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 24, the analysis for ASEX total score was based on the 75 patients who had a measure for this outcome

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).

Outcome measures

Measure	Aripiprazole Once-monthly n=75 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 24 in ASEX Total Score	-0.42 units on a scale Interval -1.74 to 0.91

SECONDARY outcome

Timeframe: Week 24

Population: This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 24, the analysis for the number of patients categorised as sexually dysfunctional was based on the 75 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=75 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale	31 participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in SWN-S Total Score	-1.57 units on a scale Interval -4.19 to 1.05

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Aripiprazole Once-monthly n=83 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in CGI-S Score	0.00 units on a scale Interval -0.14 to 0.14

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in QLS Total Score	2.08 units on a scale Interval -0.8 to 4.97

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
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 outcome

Timeframe: 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

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

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score	0.73 units on a scale Standard Deviation 4.31

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score	0.67 units on a scale Standard Deviation 4.83

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=81 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score	0.02 units on a scale Standard Deviation 2.53

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in the TooL Total Score	-0.16 units on a scale Interval -0.85 to 0.53

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in the WoRQ Total Score	-0.55 units on a scale Interval -1.2 to 0.11

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Change From Baseline to Week 12 in ASEX Total Score	-0.74 units on a scale Interval -2.03 to 0.56

SECONDARY outcome

Timeframe: Week 12

Population: This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 12, the analysis for the number of patients categorised as sexually dysfunctional was based on the 82 patients who had a measure for this outcome

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.

Outcome measures

Measure	Aripiprazole Once-monthly n=82 Participants Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale	32 participants

Adverse Events

Aripiprazole Once-monthly

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aripiprazole Once-monthly n=88 participants at risk Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Gastrointestinal disorders Gastrooesophageal reflux disease	1.1% 1/88 • Treatment to end of study (up to 28 weeks) Treatment-Emergent Adverse Events are reported in this section
Psychiatric disorders Alcoholism	1.1% 1/88 • Treatment to end of study (up to 28 weeks) Treatment-Emergent Adverse Events are reported in this section
Psychiatric disorders Dysphoria	1.1% 1/88 • Treatment to end of study (up to 28 weeks) Treatment-Emergent Adverse Events are reported in this section

Other adverse events

Measure	Aripiprazole Once-monthly n=88 participants at risk Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Investigations Weight increased	6.8% 6/88 • Treatment to end of study (up to 28 weeks) Treatment-Emergent Adverse Events are reported in this section

Additional Information

H. Lundbeck

H. Lundbeck A/S

Email: LundbeckClinicalTrials@Lundbeck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place