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Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01795547
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : December 3, 2015
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 February 18, 2013
First Posted Date  ICMJE February 20, 2013
Results First Submitted Date  ICMJE September 17, 2015
Results First Posted Date  ICMJE December 3, 2015
Last Update Posted Date March 17, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score [ Time Frame: Baseline, Week 28 ]
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). 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2013)
Mean change from Baseline in quality of life [ Time Frame: Baseline and Week 28 ]
Quality of Life Scale (QLS) total score
Change History Complete list of historical versions of study NCT01795547 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28 [ Time Frame: Week 28 ]
    The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).
  • Change From Baseline to Week 28 in CGI-S Score [ Time Frame: Baseline, Week 28 ]
    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 28 in the 'Common Objects and Activities' QLS Domain Score [ Time Frame: Baseline, Week 28 ]
    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 28 in the 'Intrapsychic Foundations' QLS Domain Score [ Time Frame: Baseline, Week 28 ]
    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 28 in the 'Interpersonal Relations' QLS Domain Score [ Time Frame: Baseline, Week 28 ]
    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 28 in the 'Instrumental Role' QLS Domain Score [ Time Frame: Baseline, Week 28 ]
    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 28 in SWN-S Total Score [ Time Frame: Baseline, Week 28 ]
    The 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 28 in the TooL Total Score [ Time Frame: Baseline, Week 28 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2013)
  • Investigator's assessment of overall effectiveness [ Time Frame: Week 28 ]
    Investigator's Assessment Questionnaire (IAQ) total score
  • Mean change from Baseline in clinical global impression [ Time Frame: Baseline and Week 28 ]
    Clinical Global Impression - Severity of Illness (CGI-S) score
  • Mean change from Baseline in quality of life using QLS [ Time Frame: Baseline and Week 28 ]
    4 QLS dimension scores
  • Mean change from Baseline in subjective well-being using SWN-S [ Time Frame: Baseline and Week 28 ]
    Subjective Well-being under Neuroleptics - short version (SWN-S) total score
  • Mean change from Baseline in tolerability and quality of life using TooL [ Time Frame: Baseline and Week 28 ]
    Tolerability and Quality of Life (TooL) total score
  • Safety and tolerability [ Time Frame: Up to 28 weeks and 4-week safety follow up ]
    Number of adverse events
  • Risk of suicidality [ Time Frame: Up to 28 weeks and 4-week safety follow up ]
    Columbia-Suicide Severity Rating Scale (C-SSRS) 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 Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Official Title  ICMJE A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Brief Summary To assess the effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR®), in a naturalistic care setting by comparing it to an existing long-acting antipsychotic, paliperidone palmitate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Aripiprazole and aripiprazole once-monthly
    Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
    Other Names:
    • Aripiprazole: Abilify®
    • Aripiprazole (extended-release injectable suspension): Abilify Maintena®
  • Drug: Paliperidone and paliperidone palmitate
    Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
    Other Names:
    • Paliperidone: Invega®
    • Paliperidone palmitate: Xeplion® or Invega® Sustenna®
Study Arms  ICMJE
  • Experimental: Aripiprazole and aripiprazole once-monthly
    Intervention: Drug: Aripiprazole and aripiprazole once-monthly
  • Active Comparator: Paliperidone and paliperidone palmitate
    Intervention: Drug: Paliperidone and paliperidone palmitate
Publications *

*   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: October 27, 2015)
295
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2013)
286
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  • The patient has schizophrenia, diagnosed according to DSM-IV-TR®.
  • The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s).
  • The patient is in need of a change in the current antipsychotic treatment and in the judgement of the investigator the patient would benefit from an extended treatment with a once-monthly formulation.
  • The patient agrees to protocol-defined use of effective contraception.

Main Exclusion Criteria:

  • The patient has any current psychiatric disorder or Axis I disorder (DSM-IV® criteria) other than schizophrenia established as the primary diagnosis.
  • The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits.
  • The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone.
  • 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 history of neuroleptic malignant syndrome.
  • The patient has or has had significant medical condition that would expose him or her to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the study including, but not limited to neurological, hepatic, renal, metabolic, haematological, immunological, gastrointestinal, pulmonary, or cardiovascular disorders.
  • 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 is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.
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 NCT01795547
Other Study ID Numbers  ICMJE 14724A
2012-002785-12 ( 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