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NCT06167577: DYSBIP

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

Completed Last updated 4 December 2024
What this trial tests

trial testing Psychometric scales (BPRS, MRS, HAM-D, SES, and GAF) monthly in Bipolar Disorder in 150 participants. Completed in 8 November 2023.

Timeline
8 November 2018
Primary endpoint
8 February 2022
8 November 2023

Quick facts

Lead sponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
StatusCompleted
Study typeOBSERVATIONAL
Enrollment150
Start date8 November 2018
Primary completion8 February 2022
Estimated completion8 November 2023
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Who can join

Adults 18 to 65, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Bipolar Disorder

Currently open trials in the same condition.

Other Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials

Trials by the same sponsor.

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Data sources for this page

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