Study of Paliperidone Palmitate 6 Month formulation for the Treatment of Patients with subjects schizophrenia (a type of mental disorder or illness characterized by abnormal social behavior and failure to understand what is real).
- Conditions
- Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]SchizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2017-001941-28-DE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 838
Each potential subject must satisfy all of the following criteria to be enrolled in the study:
1.Male or female subjects.
2.Must be 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) to 70 years of age, inclusive, at the time of informed consent.
3.Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening.
4.Must be receiving treatment with paliperidone palmitate (as either the PP1M or PP3M formulation), or injectable risperidone, or any oral antipsychotic.
a.If the treatment is paliperidone palmitate, then:
1) The dose strength must be PP1M as 100 or 150 mg eq. or PP3M as 350 or 525 mg eq.
2) The dose timing must fit the study schedule. The next injection must be due within 28 days of the first screening (or first rescreening) visit.
b.If the treatment is injectable risperidone, then the dose strength must be 50 mg, the dosing cycle must be every 2 weeks, the efficacy and tolerability must have been established as adequate with the same strength and frequency for at least 3 injection cycles before screening, and the subject must have a preference for a longer-acting injectable medication.
c.If the treatment is an oral antipsychotic, then the subject must have a valid reason to discontinue the previous treatment, such as problems with efficacy, safety, or tolerability, or preference for a long-acting injectable medication.
5.Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M or PP3M during the Screening Phase.
6.Must have a full PANSS score of <70 points at screening.
Please refer to protocol for additional inclusion criteria
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 757
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Any potential subject who meets any of the following criteria will be excluded from participating in the study:
1.Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment.
2.Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening.
3.Must not have a DSM-5 diagnosis of moderate to severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator.
4.Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia.
5Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe.
6. Must not have been treated with injectable formulations of neuroleptic drugs based on active ingredients other than risperidone or paliperidone (eg, haloperidol decanoate, fluphenazine decanoate, etc) during the 6 months before screening.
Please refer to protocol for additional exclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method