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Aripiprazole Once-monthly in Patients With Schizophrenia

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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

Tracking Information
First Submitted Date  ICMJE October 7, 2013
First Posted Date  ICMJE October 9, 2013
Results First Submitted Date  ICMJE February 17, 2016
Results First Posted Date  ICMJE May 16, 2016
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE October 2013
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
Safety and Tolerability [ Time Frame: Up to 24 weeks and 4-week safety follow up ]
Number of treatment emergent adverse events (TEAEs).
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • Safety and Tolerability [ Time Frame: Up to 24 weeks and 4-week safety follow up ]
    Number of adverse events
  • Risk of suicidality [ Time Frame: Up to 24 weeks and 4-week safety follow up ]
    Columbia-Suicide Severity Rating Scale (C-SRRS) score
Change History Complete list of historical versions of study NCT01959035 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • Change From Baseline to Week 24 in SWN-S Total Score [ Time Frame: 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 24 in CGI-S Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 12 in SWN-S Total Score [ Time Frame: 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.
  • Change From Baseline to Week 12 in CGI-S Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • Mean change from Baseline in subjective well-being using SWN-S [ Time Frame: Baseline and Week 24 ]
    Subjective Well-being under Neuroleptics - short version (SWN-S) total score
  • Mean change from Baseline in clinical global impression [ Time Frame: Baseline and Week 24 ]
    Clinical Global Impression - Severity of Illness (CGI-S) score
  • Mean change from Baseline in quality of life [ Time Frame: Baseline and Week 24 ]
    Quality of Life Scale (QLS) total score
  • Mean change from Baseline in quality of life using QLS [ Time Frame: Baseline and Week 24 ]
    4 QLS dimension scores
  • Mean change from Baseline in tolerability and quality of life using TooL [ Time Frame: Baseline and Week 24 ]
    Tolerability and Quality of Life (TooL) total score
  • Mean change from Baseline to identify individuals with sexual dysfunction [ Time Frame: Baseline and Week 24 ]
    Arizona Sexual Experience Scale (ASEX) total score
  • Mean change from Baseline in the patient's readiness to work [ Time Frame: Baseline and Week 24 ]
    The Readiness for Work Questionnaire (WoRQ) total score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aripiprazole Once-monthly in Patients With Schizophrenia
Official Title  ICMJE Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Aripiprazole once-monthly
400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Other Name: Abilify Maintena®
Study Arms  ICMJE Experimental: Aripiprazole once-monthly
Intervention: Drug: Aripiprazole once-monthly
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2015)
88
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2013)
100
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01959035
Other Study ID Numbers  ICMJE 14724B
2012-003239-47 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Otsuka Pharmaceutical Co., Ltd.
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP