A 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients withschizophrenia

H. Lundbeck A/S0 个研究点目标入组 286 人开始时间: 2013年3月21日最近更新: 2014年10月27日

适应症

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•1. The patient has schizophrenia, diagnosed according to DSM-IV-TR®.
•2. The patient has a CGI-S score from mildly ill to markedly ill at the Screening and Baseline Visit(s).
•3. 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.
•4. The patient agrees to protocol-defined use of effective contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 286
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. The patient has any current psychiatric disorder or Axis I disorder (DSMIV ® criteria) other than schizophrenia established as the primary diagnosis.
•2. The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the Screening and Baseline Visits.
•3. The patient in the investigator's judgment has shown significant intolerance and/or lack of efficacy to oral aripiprazole, paliperidone or risperidone.
•4. 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).
•5. The patient has a history of neuroleptic malignant syndrome.
•The patient has any relevant medical history or current presence of systemic disease
•6. The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

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