Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lundbeck A/S
With
Otsuka Pharmaceutical Co., Ltd.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
