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Also known as Paliperidone palmitate 3 month formulation (PP3M)
Paliperidone palmitate 3 month formulation · 1 trial · 1 indication
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission is defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
| Arm | Type | Description |
|---|---|---|
| Paliperidone palmitate 3 month formulation (PP3M) | EXPERIMENTAL | Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq.) up to 525 mg eq. based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq. |
| Name | Type | Description |
|---|---|---|
| Paliperidone palmitate 3 month formulation (PP3M) | DRUG | Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq. |
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 s...
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Paliperidone palmitate 3 month formulation is a long-acting injectable antipsychotic developed by Johnson & Johnson (ticker JNJ) for the treatment of schizophrenia. It is a small molecule formulation designed to provide symptom control with dosing every three months, and it is also known as PP3M.
Paliperidone palmitate 3 month formulation is used for the treatment of schizophrenia in adults. It is intended for patients who have been stabilized on the paliperidone palmitate 1-month formulation before transitioning to the 3-month regimen.
Paliperidone palmitate 3 month formulation targets the serotonin 5-HT2A receptor (HTR2A) and the dopamine D2 receptor (DRD2). It acts as an antagonist at both receptors, which is the mechanism underlying its antipsychotic activity in schizophrenia.
Paliperidone palmitate 3 month formulation is developed by Johnson & Johnson, which trades under the ticker JNJ. Johnson & Johnson is the company responsible for the clinical development of this long-acting injectable antipsychotic.
Paliperidone palmitate 3 month formulation is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA for any indication.
Paliperidone palmitate 3 month formulation has been studied in a completed Phase 3 trial, NCT02713282, which evaluated transition to the 3-month formulation in participants with schizophrenia previously stabilized on the 1-month formulation. The trial enrolled 306 participants across multiple countries.
Yes, paliperidone palmitate 3 month formulation is also known as PP3M. PP3M is the abbreviated name for the same long-acting injectable antipsychotic developed by Johnson & Johnson for schizophrenia.