Treatment-resistant SchizophreniaNCT06128408
The Characteristics of Treatment Resistant Schizophrenia From the Illness Onset
An observational study of Treatment-resistant Schizophrenia, run by Peking University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Treatment-resistant Schizophrenia
- What is being tested?
- risperidone, olanzapine, aripiprazole
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 13 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: schizophrenia
Who may be able to join
- 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.
Who cannot join
- Previous history of major physical diseases.
- Previous substance abuse or dependence.
- Contraindications to olanzapine, risperidone or aripiprazole.
About this study
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.
Read the detailed description
Research steps: (1) First, based on the applicant's project funded by the National Natural Science Foundation of China (National Natural Science Foundation: Precise Identification and Treatment of Treatment-Resistant First-Episode Schizophrenia), treatment-resistant first-episode schizophrenia patients (TRO) and non-treatment-resistant first-episode schizophrenia patients (None-TRO) will be included. The demographic information, disease characteristics, psychopathology, social functioning, and neurocognition data of the patients will be collected. This includes scores from the Positive and Negative Syndrome Scale (PANSS), Bech-Rafaelsen Mania Scale (BRMS), Calgary Depression Scale for Schizophrenia (CDSS), Insight into Treatment Adherence Questionnaire (ITAQ), Perceived Stress Scale- Chinese Version (PSS-CV), Childhood Trauma Questionnaire (CTQ), Abnormal Involuntary Movement Scale (AIMS), Rating Scale for Extrapyramidal Side Effects (RSESE), Clinical Global Impressions Scale (CGI), Medication Adherence Rating Scale (MARS), UKU Side Effect Rating Scale, Personal and Social Performance Scale (PSP), Premorbid Adjustment Scale (PAS), and Computerized Battery of Cognitive Tests (CBCT). All data will be anonymized and will not involve the personal privacy of the participants. (2) For TRO patients, demographic information, disease characteristics, psychopathology, social functioning, and neurocognition data will be integrated. Mathematical modeling methods such as K-Means/SVM and Convolutional Neural Networks will be used to try to establish a TRO prediction model, with predictive factors obtained through literature review, expert consultation, and data analysis.
Treatment-resistant schizophrenia: After 6 weeks of treatment with two second-generation antipsychotic drugs at an adequate dose (minimum dose for acute treatment of schizophrenia as stated in the antipsychotic drug instructions or equivalent dose of 600mg chlorpromazine), no clinical improvement is observed (CGI-S ≥ 4 or PANSS reduction rate < 50%).
- Conditions
- Treatment-resistant Schizophrenia
- Being tested
- risperidone, olanzapine, aripiprazole
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidone, olanzapine, aripiprazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | Not described Receives: Drug: risperidone, olanzapine, aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: From December 1, 2023 to October 12, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion12 Oct 2024 (estimated)
- Study completion13 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant SchizophreniaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128408
- Sponsor's protocol ID
- 2023-6-002
- Status last verified
- Oct 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Treatment Resistant Schizophrenia From the Illness Onset
- ClinicalTrials.gov ID
- NCT06128408
- Acronym / sponsor ID
- 2023-6-002
- Conditions
- Treatment-resistant Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 12 Oct 2024 (estimated)
- Study completion
- 13 Oct 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research steps: (1) First, based on the applicant's project funded by the National Natural Science Foundation of China (National Natural Science Foundation: Precise Identification and Treatment of Treatment-Resistant First-Episode Schizophrenia), treatment-resistant first-episode schizophrenia patients (TRO) and non-treatment-resistant first-episode schizophrenia patients (None-TRO) will be included. The demographic information, disease characteristics, psychopathology, social functioning, and neurocognition data of the patients will be collected. This includes scores from the Positive and Negative Syndrome Scale (PANSS), Bech-Rafaelsen Mania Scale (BRMS), Calgary Depression Scale for Schizophrenia (CDSS), Insight into Treatment Adherence Questionnaire (ITAQ), Perceived Stress Scale- Chinese Version (PSS-CV), Childhood Trauma Questionnaire (CTQ), Abnormal Involuntary Movement Scale (AIMS), Rating Scale for Extrapyramidal Side Effects (RSESE), Clinical Global Impressions Scale (CGI), Medication Adherence Rating Scale (MARS), UKU Side Effect Rating Scale, Personal and Social Performance Scale (PSP), Premorbid Adjustment Scale (PAS), and Computerized Battery of Cognitive Tests (CBCT). All data will be anonymized and will not involve the personal privacy of the participants. (2) For TRO patients, demographic information, disease characteristics, psychopathology, social functioning, and neurocognition data will be integrated. Mathematical modeling methods such as K-Means/SVM and Convolutional Neural Networks will be used to try to establish a TRO prediction model, with predictive factors obtained through literature review, expert consultation, and data analysis.
Treatment-resistant schizophrenia: After 6 weeks of treatment with two second-generation antipsychotic drugs at an adequate dose (minimum dose for acute treatment of schizophrenia as stated in the antipsychotic drug instructions or equivalent dose of 600mg chlorpromazine), no clinical improvement is observed (CGI-S ≥ 4 or PANSS reduction rate < 50%).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | – | Drug: risperidone, olanzapine, aripiprazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- schizophrenia
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous history of major physical diseases.
- Previous substance abuse or dependence.
- Contraindications to olanzapine, risperidone or aripiprazole.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risperidone, olanzapine, aripiprazoleParticipants 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. | Drug | schizophrenia |
Primary outcome
treatment-resistant schizophrenia
Time frame: From December 1, 2023 to October 12, 2024
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%).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment-resistant Schizophrenia, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment-resistant schizophrenia (time frame: From December 1, 2023 to October 12, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.