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

Lundbeck

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Aripiprazole and aripiprazole once-monthly

Drug: Paliperidone and paliperidone palmitate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01795547

14724A

2012-002785-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

295 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.