Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole and aripiprazole once-monthly; Paliperidone and paliperidone palmitate
Intervention description: 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.; 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.
Intervention MeSH terms: Aripiprazole; Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

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.