Phase 3 N=295 Randomized Treatment

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

Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT01795547 ↗

Enrolled (actual)

295

Serious AEs

7.8%

Results posted

Dec 2015

Primary outcome: Primary: Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score — 7.47; 2.80 units on a scale — p=0.036

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Aripiprazole and aripiprazole once-monthly (Drug); Paliperidone and paliperidone palmitate (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: H. Lundbeck A/S
Primary completion: Sep 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score	7.47; 2.80	0.036 sig
SECONDARY Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28	32.32; 33.81	0.043 sig
SECONDARY Change From Baseline to Week 28 in CGI-S Score	-0.75; -0.46	0.004 sig
SECONDARY Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score	0.52; 0.18	0.149
SECONDARY Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score	2.25; 0.50	0.039 sig
SECONDARY Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score	3.24; 1.47	0.070
SECONDARY Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score	1.76; 0.83	0.130
SECONDARY Change From Baseline to Week 28 in SWN-S Total Score	4.82; 3.81	0.561
SECONDARY Change From Baseline to Week 28 in the TooL Total Score	-1.75; -1.05	0.095

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.

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Data sourced from ClinicalTrials.gov (NCT01795547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.