An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.
This study, conducted at the Shanghai Mental Health Center, aims to compare changes in treatment efficacy and the frequency and severity of adverse reactions in patients with schizophrenia who have experienced treatment failure, before and after implementing a pharmacogenomics-based precision medication guidance strategy. The research is set in real-world conditions, without a predetermined treatment regimen for participants; instead, medication optimization is guided by pharmacogenomic testing results. Following the receipt of precision medication recommendations for each participant, the study physicians optimize the treatment regimen based on these recommendations and their clinical expertise. Optimization may involve adjusting the dose of current medications (if the existing regimen is largely suitable), switching medications (in cases of inappropriate treatment), or modifying the dose or replacing one of the combined medications (to manage drug-drug interactions). The rationality of the medication regimen will be assessed at the end of weeks 4 and 8, with additional recommendations provided as needed. Treatment effectiveness and safety will be evaluated during follow-up visits at these intervals. A total of 400 patients are planned to be included in the study.
Study Type
OBSERVATIONAL
Enrollment
400
Shanghai Mental Health Center
Shanghai, China
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.
Time frame: 4 weeks and 8 weeks
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.
Time frame: 4 weeks and 8 weeks
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
Time frame: 4 weeks and 8 weeks
Clinical Laboratory Tests
Test data of the Hematology, Serum chemistry, Lipid Panel, Glycated Hemoglobin, Urinalysis, etc. will be collocted.
Time frame: 4 weeks and 8 weeks
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).
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Time frame: 4 weeks and 8 weeks
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
BARS consisted of 4 items, and the first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation was made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. The total score ranges from 0 to 14. The higher number indicates a worse outcome.
Time frame: 4 weeks and 8 weeks
Safety Assessment by Simpson-Angus Scale(SAS)
The minimum of each item (Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS (Simpson-Angus Scale) is 0, and the maximum is 4. The minimum total score in the SAS is 0, and the maximum is 40. The higher number is worse outcome.
Time frame: 4 weeks and 8 weeks
Safety Assessment by Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
The Abnormal Involuntary Movement Scale (AIMS) Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Time frame: 4 weeks and 8 weeks