Clinical trial NCT01795547: Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Official title: A 28-week, Randomised, Open-label Study Evaluating the Effectiveness of Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2013-02-20
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score
timeFrame: Baseline, Week 28
Secondary outcomes:
measure: Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28
timeFrame: Week 28
measure: Change From Baseline to Week 28 in CGI-S Score
timeFrame: Baseline, Week 28
measure: Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score
timeFrame: Baseline, Week 28
measure: Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score
timeFrame: Baseline, Week 28
measure: Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score
timeFrame: Baseline, Week 28
measure: Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score
timeFrame: Baseline, Week 28
measure: Change From Baseline to Week 28 in SWN-S Total Score
timeFrame: Baseline, Week 28
measure: Change From Baseline to Week 28 in the TooL Total Score
timeFrame: Baseline, Week 28
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: US002
state: California
city: San Diego
country: United States
facility: US006
state: California
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Potkin SG, Loze JY, Forray C, Baker RA, Sapin C, Peters-Strickland T, Beillat M, Nylander AG, Hertel P, Nitschky Schmidt S, Eramo A, Hansen K, Naber D. Multidimensional Assessment of Functional Outcomes in Schizophrenia: Results From QUALIFY, a Head-to-Head Trial of Aripiprazole Once-Monthly and Paliperidone Palmitate. Int J Neuropsychopharmacol. 2017 Jan 1;20(1):40-49. doi: 10.1093/ijnp/pyw093.
citation: Naber D, Hansen K, Forray C, Baker RA, Sapin C, Beillat M, Peters-Strickland T, Nylander AG, Hertel P, Andersen HS, Eramo A, Loze JY, Potkin SG. Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia. Schizophr Res. 2015 Oct;168(1-2):498-504. doi: 10.1016/j.schres.2015.07.007. Epub 2015 Jul 29.