The Characteristics of Treatment Resistant Schizophrenia From the Illness Onset

NCT06128408 | Unknown

• 1 other identifier: 2023-6-002
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Previous long-term follow-up studies on patients with first-episode schizophrenia have shown that up to 30% of patients who have never received antipsychotic medication treatment do not experience symptom relief or have poor treatment response after standard antipsychotic medication treatment, becoming treatment-resistant schizophrenia (TRS). Moreover, in long-term follow-up, patients with treatment-resistant schizophrenia from the illness onset (TRO) account for 80% of all TRS patients. Preliminary studies abroad have found that TRO patients have characteristics such as early age of onset, male predominance, prominent negative symptoms, high proportion of positive family history, and long duration of untreated psychosis, but there is still no consistent conclusion on the pathological mechanisms. There is currently no research on this type of patient in China, and there are difficulties in early diagnosis of TRO patients in clinical practice. This study aims to establish a TRO prediction model by integrating data on demographics, disease characteristics, psychopathology, social function, and neurocognition from a cohort of patients with first-episode schizophrenia. Mathematical modeling methods such as K-Means/SVM and convolutional neural networks will be used. Therefore, in patients with untreated first-episode schizophrenia, early and accurate identification of TRO patients at the initial diagnosis stage and treatment with clozapine is particularly important for potentially shortening the treatment period and reducing the personal and societal burden of TRO patients. Based on the progress of existing research and the previous work of the research team, we speculate that TRO patients have unique clinical features. This project will establish a TRO prediction model based on multidimensional clinical data using mathematical modeling methods. From a clinical application perspective, the study selects TRO model prediction factors based on existing clinical assessment methods, making the model highly clinically applicable and generalizable. By establishing a TRO prediction model, not only can high-risk TRO patients be identified early in the initial diagnosis stage, enabling appropriate clinical treatment interventions, but it can also provide new insights into the future clinical treatment of TRO, promote the development of early and personalized precision identification and treatment of TRO, and improve long-term prognosis and reduce the burden of the disease for patients.

Conditions

Treatment-resistant Schizophrenia

Outcome Measures

Primary Outcomes (1)

• treatment-resistant schizophrenia

  Treated with sufficient dosage of two types of second-generation antipsychotic medications (at least the minimum dose for acute phase treatment of schizophrenia or an equivalent dose of 600mg chlorpromazine) for 6 weeks, but did not achieve clinical improvement (CGI-S≥4 or PANSS reduction rate \<50%).

  From December 1, 2023 to October 12, 2024

Study Arms (1)

schizophrenia

Drug: risperidone, olanzapine, aripiprazole

Interventions

risperidone, olanzapine, aripiprazole DRUG

Participants from the retrospective cohort were randomly assigned to one of the three drug groups of risperidone, olanzapine and aripiprazole for a period of 1 years of treatment.

schizophrenia

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

schizophrenia

You may qualify if:

• Having a diagnosis of schizophrenics based on the patient edition of the Structured Clinical Interview for Axis I Diagnostic and Statistical Manual-IV Axis I Disorders (SCID).
• Age 18-45 years.
• First episode of schizophrenia.
• Course of disease ≤ 3 years.
• Previous continuous medication ≤ 4 weeks, cumulative intermittent medication ≤ 12 weeks.
• Be able to understand the interview content and sign written informed consent.

You may not qualify if:

• Previous history of major physical diseases.
• Previous substance abuse or dependence.
• Contraindications to olanzapine, risperidone or aripiprazole.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant

Interventions

Risperidone; Olanzapine; Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines; Quinolones; Quinolines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2023
• Primary Completion: October 12, 2024
• Study Completion: October 13, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-10