About this trial
An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
Age between ≥18 and <65 years.
Currently receiving inpatient or outpatient psychiatric treatment.
Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
Disqualifiers
Presence of organic brain disease or a severe and/or unstable physical condition.
Substance abuse or dependence within the past 6 months or currently.
Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
Pregnant or breastfeeding women.
Trial population
The study population includes outpatients or inpatients receiving treatment at the Shanghai Mental Health Center in Shanghai, China
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8
The Positive and Negative Syndrome Scale (PANSS) provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. Score range 30-210. A higher score means a worse outcome.
Secondary outcomes
Change in the Calgary Depression Scale for Schizophrenia (CDSS)
The Calgary Depression Scale for Schizophenia (CDSS) is a 9-item scale used to rate the depressive symptoms in patients with schizophrenia. For each CDSS item, symptom severity was rated on a 3-point scale, from 0=absent to 3=severe. The CDSS total score ranges from 0 to 27 with a higher score indicating a greater severity of symptoms.
Change in the Clinical Global Impression of Severity (CGI-S)
The Clinical Global Impression of Severity (CGI-S) rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening
Clinical Laboratory Tests
Test data of the Hematology, Serum chemistry, Lipid Panel, Glycated Hemoglobin, Urinalysis, etc. will be collocted.
Safety Assessment by the Treatment Emergent Symptom Scale (TESS) score
The Treatment Emergent Symptom Scale (TESS) consists of behavioral toxicity, laboratory abnormalities, nervous system, automatic nervous system, cardiovascular system and six other aspects, was used to evaluate adverse drug reactions based on the scores, ranging from 0 to 4 (the higher the score, the more serious the adverse reactions).
Other outcomes
Change in the Medication Satisfaction Questionnaire (MSQ) score
The medication satisfaction questionnaire (MSQ) is a single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied.
Change in the Drug Attitude Inventory (DAI)-10 Score
DAI, a 10-item scale to assess how the attitude of schizophrenia patients toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranges from -10 to 10, where a positive score indicated a positive subjective response (compliant), whilst a negative score indicated non-compliance.
Change in the Personal and Social Performance Scale (PSP)
The PSP is a 100-point validated clinician-rated scale that assesses the degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviors rated on a 6-point scale (1=absent to 6=very severe). Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty), with higher scores indicating better function.
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