Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia

ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJiangsu Province Nanjing Brain Hospital

About this trial

To evaluate the efficacy of Paliperidone Palmitate Injection in replacing oral antipsychotics for the treatment of schizophrenia and its impact on social function

Eligibility criteria

Qualifiers

Outpatients or inpatients meeting DSM-5 diagnostic criteria forschizophrenia;

Aged 18-65 years (inclusive), regardless of gender;

Currently receiving first- or second-generation oral antipsychotics (excluding clozapine) with stable condition as assessed by the investigator, and PANSS total score ≤80 at screening and baseline;

Signed informed consent by the patient and/or guardian;

Disqualifiers

Comorbid psychiatric diagnoses other than schizophrenia;

Severe physical diseases, intellectual disability, organic brain disorders, or mental disorders due to physical illnesses;

QTc interval >450 ms (male) or >460 ms (female);

History of psychoactive substance abuse (excluding tobacco) within the past 12 months, or significant suicidal/violent tendencies;

Trial design

Treatments tested in this trial

  • Paliperidone Palmitate Injection (PP1M)

Treatment groups

120 Participants
are divided into 1 treatment group