Aripiprazole Once-monthly Versus Paliperidone Palmitate in Adult Patients With Schizophrenia
- Conditions
- SchizophreniaMedDRA version: 14.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2012-002785-12-IT
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 286
? The patient has schizophrenia, diagnosed according to DSM-IV TR™.
? The patient is a man or woman, aged =18 and =60 years.
? The patient has been prescribed oral antipsychotic treatment for the full 3 months prior to the Screening Visit.
? The patient has CGI-S score =3 (mildly ill) and =5 (markedly ill) at the Screening and Baseline Visits .
? 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, including
but not limited to any of the following reasons:
- lack of adequate response to his or her current antipsychotic medication,
- poor tolerability to his or her current antipsychotic medication,
- lack of adherence to his or her current antipsychotic medication.
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
The patient has any current psychiatric disorder or Axis I disorder (DSM-IV™ criteria) other than
schizophrenia established as the primary diagnosis.
? The patient has a substance use disorder (except nicotine) which according to the investigator’s judgment may
compromise the patient’s ability to comply with the study procedures, or preclude the benefits of the study
medication.
? The patient in the investigator’s judgment has shown significant intolerance and/or lack of efficacy to oral
aripiprazole, paliperidone or risperidone, in a manner that would preclude benefiting from the study
medication if randomised to the same IMP during the study.
? The patient has been treated with a long-acting injectable atypical antipsychotic drugs such as olanzapine,
paliperidone, or aripiprazole <6 months prior to the Screening Visit.
? The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit or between the
Screening and Baseline Visits.
? The patient is hospitalised at the time of the Screening Visit for a period longer than 3 months.
? The patient is considered resistant to antipsychotic treatment according to the investigator’s judgement, or has
a history of failure to respond to clozapine treatment, or a history of responding only to clozapine treatment.
? The patient is at significant risk of harming himself/herself or others according to the investigator’s judgement
or as indicated by an answer of yes” to questions 4 or 5 on the C-SSRS at the Screening or Baseline Visit.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Effectiveness of aripiprazole once-monthly in the maintenance treatment of patients with a diagnosis of schizophrenia;Secondary Objective: Effectiveness of aripiprazole once-monthly versus paliperidone palmitate;Primary end point(s): variazione media dal Basale alla Settimana 28 nel punteggio totale di QLS;Timepoint(s) of evaluation of this end point: Baseline and Week 28
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? IAQ total score at Week 28<br>? Clinical Global Impression: mean change from Baseline to Week 28 in CGI-S score<br>? Mean change from Baseline to Week 28 in the 4 QLS dimension scores<br>? Mean change from Baseline to Week 28 in SWN-S total score<br>? Mean change from Baseline to Week 28 in the TooL total score;Timepoint(s) of evaluation of this end point: 1. Week 28<br><br>2. Baseline and Week 28<br><br>3. Baseline and Week 28<br><br>4. Baseline and Week 28<br><br>5. Baseline and Week 28<br><br>6. Up to 28 weeks and 4-week safety follow up<br><br>7. Up to 28 weeks and 4-week safety follow up