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Trial record 49 of 407 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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole once-monthly Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Flexible-dose Extension Study of Aripiprazole Once-monthly in Patients With Schizophrenia
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Aripiprazole once-monthly Drug: Aripiprazole once-monthly
400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
Other Name: Abilify Maintena®




Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Up to 24 weeks and 4-week safety follow up ]
    Number of treatment emergent adverse events (TEAEs).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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).

  11. 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.

  12. 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.

  13. 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).

  14. 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.

  15. 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

  16. 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

  17. 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

  18. 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.

  19. 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).

  20. 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.

  21. 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).

  22. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959035


Locations
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United States, California
US006
San Diego, California, United States, 92102
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Additional Information:
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01959035     History of Changes
Other Study ID Numbers: 14724B
2012-003239-47 ( EudraCT Number )
First Posted: October 9, 2013    Key Record Dates
Results First Posted: May 16, 2016
Last Update Posted: March 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Aripiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists