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Trial record 49 of 408 for:    ARIPIPRAZOLE

Aripiprazole Once-monthly in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01959035
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : May 16, 2016
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Aripiprazole once-monthly
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description 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
Period Title: Overall Study
Started 88
Completed 77
Not Completed 11
Reason Not Completed
Adverse Event             5
Withdrawal by Subject             4
Lost to Follow-up             1
Other (no primary reason given)             1
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
Demographic data is based on all patients who received at least one dose of IMP in Study 14724B.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
43.4  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
36
  40.9%
Male
52
  59.1%
1.Primary Outcome
Title Safety and Tolerability
Hide Description Number of treatment emergent adverse events (TEAEs).
Time Frame Up to 24 weeks and 4-week safety follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety data is based on all patients who received at least one dose of investigational medicinal product (IMP) in Study 14724B.
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 88
Measure Type: Number
Unit of Measure: number of events
65
2.Secondary Outcome
Title Change From Baseline to Week 24 in SWN-S Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.19
(-2.08 to 2.45)
3.Secondary Outcome
Title Change From Baseline to Week 24 in CGI-S Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.10
(-0.26 to 0.06)
4.Secondary Outcome
Title Change From Baseline to Week 24 in QLS Total Score
Hide Description 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 78
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.32
(-1.21 to 5.85)
5.Secondary Outcome
Title Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.21  (1.29)
6.Secondary Outcome
Title Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.72  (5.03)
7.Secondary Outcome
Title Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.58  (6.54)
8.Secondary Outcome
Title Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.42  (4.54)
9.Secondary Outcome
Title Change From Baseline to Week 24 in the TooL Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.47
(-1.16 to 0.22)
10.Secondary Outcome
Title Change From Baseline to Week 24 in the WoRQ Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.53
(-1.21 to 0.15)
11.Secondary Outcome
Title Change From Baseline to Week 24 in ASEX Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 75
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.42
(-1.74 to 0.91)
12.Secondary Outcome
Title Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: participants
31
13.Secondary Outcome
Title Change From Baseline to Week 12 in SWN-S Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.57
(-4.19 to 1.05)
14.Secondary Outcome
Title Change From Baseline to Week 12 in CGI-S Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 83
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.00
(-0.14 to 0.14)
15.Secondary Outcome
Title Change From Baseline to Week 12 in QLS Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.08
(-0.80 to 4.97)
16.Secondary Outcome
Title Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.10  (1.16)
17.Secondary Outcome
Title Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.73  (4.31)
18.Secondary Outcome
Title Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.67  (4.83)
19.Secondary Outcome
Title Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.02  (2.53)
20.Secondary Outcome
Title Change From Baseline to Week 12 in the TooL Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.16
(-0.85 to 0.53)
21.Secondary Outcome
Title Change From Baseline to Week 12 in the WoRQ Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.55
(-1.20 to 0.11)
22.Secondary Outcome
Title Change From Baseline to Week 12 in ASEX Total Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.74
(-2.03 to 0.56)
23.Secondary Outcome
Title Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description:
Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Overall Number of Participants Analyzed 82
Measure Type: Number
Unit of Measure: participants
32
Time Frame Treatment to end of study (up to 28 weeks)
Adverse Event Reporting Description Treatment-Emergent Adverse Events are reported in this section
 
Arm/Group Title Aripiprazole Once-monthly
Hide Arm/Group Description Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
All-Cause Mortality
Aripiprazole Once-monthly
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Aripiprazole Once-monthly
Affected / at Risk (%)
Total   3/88 (3.41%) 
Gastrointestinal disorders   
Gastrooesophageal reflux disease  1  1/88 (1.14%) 
Psychiatric disorders   
Alcoholism  1  1/88 (1.14%) 
Dysphoria  1  1/88 (1.14%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aripiprazole Once-monthly
Affected / at Risk (%)
Total   6/88 (6.82%) 
Investigations   
Weight increased  1  6/88 (6.82%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. Lundbeck
Organization: H. Lundbeck A/S
EMail: LundbeckClinicalTrials@Lundbeck.com
Layout table for additonal information
Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01959035     History of Changes
Other Study ID Numbers: 14724B
2012-003239-47 ( EudraCT Number )
First Submitted: October 7, 2013
First Posted: October 9, 2013
Results First Submitted: February 17, 2016
Results First Posted: May 16, 2016
Last Update Posted: March 17, 2017