Evaluating Pharmacogenomics-Based Pharmacotherapy in Real-World Settings for Schizophrenia

Not yet recruiting

• Conditions: Schizophenia Disorder

• Registration Number: NCT06700967
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

An 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.

Detailed Description

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2024-12-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).

2. Age between ≥18 and <65 years.

3. Currently receiving inpatient or outpatient psychiatric treatment.

4. Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:

   1. Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
   2. Antipsychotic treatment within the therapeutic dosage range for more than 4 weeks, with the presence of at least two items of the Positive and Negative Syndrome Scale (PANSS) (P1, P2, P3, N1, N4, N6, G5, and G9) score ≥4, or a total PANSS score >70, or a CGI-S score ≥4.
   3. Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.

5. Understand the study requirements and provide written informed consent to participate; a signed and dated informed consent form (ICF) will be obtained from each patient before participation in the study.

Exclusion Criteria

1. Presence of organic brain disease or a severe and/or unstable physical condition.
2. Substance abuse or dependence within the past 6 months or currently.
3. Presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide.
4. Pregnant or breastfeeding women.
5. The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8	4 weeks and 8 weeks	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 Outcome Measures

Name	Time	Method
Change in the Calgary Depression Scale for Schizophrenia (CDSS)	4 weeks and 8 weeks	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)	4 weeks and 8 weeks	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	4 weeks and 8 weeks	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	4 weeks and 8 weeks	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).
Safety Assessment by Barnes Akathisia Rating Scale(BARS)	4 weeks and 8 weeks	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.
Safety Assessment by Simpson-Angus Scale(SAS)	4 weeks and 8 weeks	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.
Safety Assessment by Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score	4 weeks and 8 weeks	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.

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, China