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

November 20, 2024 updated by: Shanghai Mental Health Center

A Precision Medication Guidance Model for Schizophrenia Based on Pharmacogenomics and Physiologically Based Pharmacokinetics: a Real-World Observational Study

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

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population includes outpatients or inpatients receiving treatment at the Shanghai Mental Health Center in Shanghai, China

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 4 and Week 8
Time Frame: 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.
4 weeks and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Calgary Depression Scale for Schizophrenia (CDSS)
Time Frame: 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.
4 weeks and 8 weeks
Change in the Clinical Global Impression of Severity (CGI-S)
Time Frame: 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
4 weeks and 8 weeks
Clinical Laboratory Tests
Time Frame: 4 weeks and 8 weeks
Test data of the Hematology, Serum chemistry, Lipid Panel, Glycated Hemoglobin, Urinalysis, etc. will be collocted.
4 weeks and 8 weeks
Safety Assessment by the Treatment Emergent Symptom Scale (TESS) score
Time Frame: 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).
4 weeks and 8 weeks
Safety Assessment by Barnes Akathisia Rating Scale(BARS)
Time Frame: 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.
4 weeks and 8 weeks
Safety Assessment by Simpson-Angus Scale(SAS)
Time Frame: 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.
4 weeks and 8 weeks
Safety Assessment by Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score
Time Frame: 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.
4 weeks and 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Medication Satisfaction Questionnaire (MSQ) score
Time Frame: 8 weeks
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.
8 weeks
Change in the Drug Attitude Inventory (DAI)-10 Score
Time Frame: 8 weeks
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.
8 weeks
Change in the Personal and Social Performance Scale (PSP)
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC2021ZD02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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