A Clinical Trial to Compare the Efficacy and Safety of WAS123 Versus Daily Aripiprazole in the Maintenance Treatment of Patients With Schizophrenia.

Korábbi kezelés

• Participants who had not responded adequately to previous aripiprazole trials;
• Participants who had used depot antipsychotics or undergone electroconvulsive therapy in the last 3 months;

Más betegség

• Participants with schizophrenia refractory or resistant to antipsychotic treatment (therapeutic failure with 2 different antipsychotics, after treatment for at least 4 weeks at the maximum tolerated dose);
• History of organic mental disorders, moderate to severe intellectual disability, or another psychiatric disorder with psychotic symptoms other than schizophrenia;
• History of epilepsy, neuroleptic malignant syndrome, clinically relevant tardive dyskinesia, or other medical condition that would expose the participant to undue risk or interfere with trial assessments;
• Participants with known allergy or hypersensitivity to the components of the medications used during the clinical trial;

Laborértékek

• Any clinical or laboratory findings that were interpreted by the principal investigator as a risk to the participant's participation in the clinical trial or the presence of uncontrolled chronic disease(s);
• Participants with previous cardiac events, such as tachycardia or bradyarrhythmias, or any significant prolongation of the QT interval on the electrocardiogram (ECG);

Egyéb

• Diagnosis of substance dependence, including alcohol and benzodiazepines, but excluding nicotine and caffeine;
• Participants who were pregnant, breastfeeding, or planning to become pregnant, or female participants of childbearing potential who were not using a reliable method of contraception;
• Research participant who participated in clinical trial protocols in the last 12 months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator considered that there could be direct benefit to them.

• Participants aged 18 to 65 years with the ability to confirm voluntary participation and who agreed to all trial purposes by signing and dating the ICF in duplicate.
• Diagnosis of schizophrenia according to DSM-5 diagnostic criteria and who:
  • At Screening:
  • Were stable on aripiprazole, considering a minimum period of 4 weeks without dose adjustment, or
  • Had an inadequate response to another antipsychotic; or
  • Had tolerance issues (e.g., extrapyramidal symptoms, metabolic problems) with the current antipsychotic; or
  • Were treatment-naive
  • At randomization:
  • Were stable on aripiprazole, considering a minimum period of 4 weeks without dose adjustment.
  • Participants who met all of the following criteria were considered stable:
  • Not hospitalized;
  • Total Positive and Negative Syndrome Scale (PANSS) score ≤80;
  • Score ≤4 on individual PANSS items (P1, P2, P3, and P6);
  • CGI-S score ≤4 (moderately ill);
  • CGI-SS score ≤2 (mildly suicidal)