Schizofrenia split personality
Conditions
Interventions
Subjects will receive their first dose of PP3M on Day 1 (Visit 2 [Baseline]).
The first dose of PP3M should be initiated in place of the next scheduled dose
of PP1M (±7 days). The PP3M dose should b
PP1M = paliperidone palmitate 1-month formulation
PP3M = paliperidone
palmitate 3-month formulation.
Note there is no equivalent dose of PP3M for 25 mg eq. (36 mg) PP1M
therefore,
subjects stabilized on a PP1M dose of 25 mg (36 mg) within the last 4 months
before the first injection of PP3M are not eligible to enter this study (see
Exclusion Criteria).
Following
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Meets Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a diagnosis of schizophrenia * Able to read, understand, and sign the informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study * Willing and able to fill out self-administered questionnaires * Willing and able to adhere to the prohibitions and restrictions specified in the protocol * A woman of childbearing potential must have a negative urine pregnancy test at Screening and baseline * A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug
Exclusion criteria
Exclusion criteria: * His/her psychiatric diagnosis is due to direct pharmacological effects of a substance (example, a drug of abuse or medication) or a general medical condition (example, clinically notable hypothyroidism, organic brain disorder) *has a current DSM-5 diagnosis of dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, autistic disorder, or intellectual disabilities and/or meets the DSM-5 definition of moderate to severe substance use disorder (except for nicotine or caffeine) within 6 months prior to screening. However, subjects with mild or moderate substance use disorder, with the exception of intravenous drug use, will be eligible for enrollment." * Experienced intolerable side effects during treatment with paliperidone palmitate 1-month formulation (PP1M) * Has a known hypersensitivity to paliperidone or risperidone * Has received any other long-acting injectable antipsychotic medication other than PP1M within the last 4 months before the first injection of the study drug paliperidone palmitate 3-month formulation (PP3M) * Has received clozapine during the last 3 months before the Screening visit. * Is considered to be at imminent risk of suicide, even after clinical intervention * Has a serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities * Has a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome * Is a woman who is pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of PP3M * has participated in an investigational drug trial in the 30 days prior to the screening visit or is currently enrolled in an investigational study*Dementia related psychosis* and *Inherited or acquired long QT interval syndrome* are implicitly included within exclusion criterion 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY EVALUATIONS Efficacy assessments include the PANSS, CGI-C, CGI-S, PSP, and the WHODAS 2.0 scales. | — |
Secondary
| Measure | Time frame |
|---|---|
| OTHER EVALUATIONS Well-being and quality of life will be rated by the subject using the SWN-S and SQLS-R4, respectively. Quality of life will also be assessed using the clinician-rated QLS. Satisfaction with medication will be rated by the subject (using the MSQ) and by the physician (using a 7-point categorical scale). Consequences of the subject's illness on the designated caregiver will be assessed using the IEQ. EXPLORATORY EVALUATIONS Medical resource use (measured using the HRUQ), goal setting and goal attainment (measured using GAS), and a Quantitative Assessment of Daily Activities will be evaluated as exploratory endpoints. SAFETY EVALUATIONS Safety will be assessed through evaluation of adverse events, extrapyramidal symptoms (using the ESRS), vital signs, and changes in body weight and BMI. A urine pregnancy test will be performed in females of childbearing potential at screening, before each PP3M injection, and at study endpoint. | — |
Countries
Netherlands
Outcome results
None listed