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NCT06167577Completed

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

Dysbindin-antipsychotics Psychophamarcogenetics: a Mouse-human Translational Study Towards Personalized Healthcare in Bipolar Disorders GR-2016-02362413

Source: ClinicalTrials.gov · Last updated 4 Dec 2024

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
150 (actual)
First submitted
10 Nov 2023
Start date
8 Nov 2018
Primary completion date
8 Feb 2022
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
NCT number
NCT06167577

What you commit to

  • Study type: Observational
  • Participants enrolled: 150
  • From 8 Nov 2018 to the primary completion date, 8 Feb 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Comorbidity with other psychiatric disorders;
  • comorbidity with neurological disorders, with damage to the brain and with deficits intellectual;

Other

  • pregnancy;
  • current and past substance abuse.

Who the study is looking for

  • DB diagnoses, made by the use of the structured clinical interview based on the DSM-5 criteria (SCID-CV);
  • Therapy with an atypical antipsychotic (aripiprazole or quetiapine or olanzapine) in combination with a mood stabilizer (lithium or another mood stabilizer mood), according to the standard of care.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.