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Dysbindin-antipsychotics Psychophamarcogenetics: a Mouse-human Translational Study Towards Personalized Healthcare in Bipolar Disorders

NCT06167577 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-12-04

No results posted yet for this study

Summary

We will conduct an observational study involving a preliminary long-term follow-up designed to test how dysbindin-1 gene expression can modulate the efficacy of treatments with antipsychotics on clinical and neuropsychological outcomes. We will recruit 150 patients diagnosed with DB who required therapy with an atypical antipsychotic (aripiprazole or quetiapine or olanzapine) in combination with a medication mood stabilizer (lithium or other mood stabilizer), according to the standards of DB treatment. Treatment will be maintained stably for at least 6 months, unless the patient's clinical evolution makes a therapeutic switch inevitable. In light of the data in mice, we will correlate the clinical/neuropsychological response to antipsychotics with the presence of the functional DysBray haplotype of the DTNBP-1 gene, which has in the general population a relatively high prevalence (about 25 percent).

Conditions

Interventions

DIAGNOSTIC_TEST

Psychometric scales (BPRS, MRS, HAM-D, SES, and GAF) monthly

we will correlate the clinical/neuropsychological response to antipsychotics with the presence of the functional DysBray haplotype of the DTNBP1 gene

Sponsors & Collaborators

  • ASST Santi Paolo e Carlo

    collaborator OTHER

  • Asst Melegnano e Martesana

    collaborator OTHER_GOV

  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2022-02-08
Completion
2023-11-08

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06167577 on ClinicalTrials.gov