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

NCT06700967 | Not Yet Recruiting DMC

• 1 other identifier: CRC2021ZD02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophenia Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks and 8 weeks

Secondary Outcomes (7)

• Change in the Calgary Depression Scale for Schizophrenia (CDSS)

  4 weeks and 8 weeks

• Change in the Clinical Global Impression of Severity (CGI-S)

  4 weeks and 8 weeks

• Clinical Laboratory Tests

  4 weeks and 8 weeks

• Safety Assessment by the Treatment Emergent Symptom Scale (TESS) score

  4 weeks and 8 weeks

• Safety Assessment by Barnes Akathisia Rating Scale(BARS)

  4 weeks and 8 weeks

Other Outcomes (3)

• Change in the Medication Satisfaction Questionnaire (MSQ) score

  8 weeks

• Change in the Drug Attitude Inventory (DAI)-10 Score

  8 weeks

• Change in the Personal and Social Performance Scale (PSP)

  8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Suffer from schizophrenia (as assessed in agreement with ICD-11 criteria).
• Age between ≥18 and \<65 years.
• Currently receiving inpatient or outpatient psychiatric treatment.
• Experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range:
• Standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication.
• 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.
• Other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians.
• 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.

You may not qualify if:

• 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.
• The presence of any other conditions that may render the individual ineligible for participation in this clinical trial.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

Related Publications (7)

• Caudle KE, Sangkuhl K, Whirl-Carrillo M, Swen JJ, Haidar CE, Klein TE, Gammal RS, Relling MV, Scott SA, Hertz DL, Guchelaar HJ, Gaedigk A. Standardizing CYP2D6 Genotype to Phenotype Translation: Consensus Recommendations from the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group. Clin Transl Sci. 2020 Jan;13(1):116-124. doi: 10.1111/cts.12692. Epub 2019 Oct 24.

  PMID: 31647186 BACKGROUND

• Gaedigk A, Simon SD, Pearce RE, Bradford LD, Kennedy MJ, Leeder JS. The CYP2D6 activity score: translating genotype information into a qualitative measure of phenotype. Clin Pharmacol Ther. 2008 Feb;83(2):234-42. doi: 10.1038/sj.clpt.6100406. Epub 2007 Oct 31.

  PMID: 17971818 BACKGROUND

• Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14.

  PMID: 36115192 BACKGROUND

• Lindenmayer JP, Citrome L, Khan A, Kaushik S, Kaushik S. A randomized, double-blind, parallel-group, fixed-dose, clinical trial of quetiapine at 600 versus 1200 mg/d for patients with treatment-resistant schizophrenia or schizoaffective disorder. J Clin Psychopharmacol. 2011 Apr;31(2):160-8. doi: 10.1097/JCP.0b013e31820f4fe0.

  PMID: 21346616 BACKGROUND

• Wojtyniak JG, Selzer D, Schwab M, Lehr T. Physiologically Based Precision Dosing Approach for Drug-Drug-Gene Interactions: A Simvastatin Network Analysis. Clin Pharmacol Ther. 2021 Jan;109(1):201-211. doi: 10.1002/cpt.2111. Epub 2020 Dec 6.

  PMID: 33280091 BACKGROUND

• Hahn M, Roll SC. The Influence of Pharmacogenetics on the Clinical Relevance of Pharmacokinetic Drug-Drug Interactions: Drug-Gene, Drug-Gene-Gene and Drug-Drug-Gene Interactions. Pharmaceuticals (Basel). 2021 May 20;14(5):487. doi: 10.3390/ph14050487.

  PMID: 34065361 BACKGROUND

• Lieberman JA, Stroup TS, McEvoy JP, Swartz MS, Rosenheck RA, Perkins DO, Keefe RS, Davis SM, Davis CE, Lebowitz BD, Severe J, Hsiao JK; Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005 Sep 22;353(12):1209-23. doi: 10.1056/NEJMoa051688. Epub 2005 Sep 19.

  PMID: 16172203 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample

Central Study Contacts

YU, Prof.

CONTACT

+86 021-3477-3299; yushunying@smhc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 22, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)