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NCT06167577: DYSBIP
Dysbindin-antipsychotics Psychophamarcogenetics: a Mouse-human Translational Study Towards Personalized Healthcare in Bipolar Disorders
trial testing Psychometric scales (BPRS, MRS, HAM-D, SES, and GAF) monthly in Bipolar Disorder in 150 participants. Completed in 8 November 2023.
8 February 2022
Quick facts
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 8 November 2018 |
| Primary completion | 8 February 2022 |
| Estimated completion | 8 November 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Psychometric scales (BPRS, MRS, HAM-D, SES, and GAF) monthly
Conditions studied
- Bipolar Disorder — all drugs for Bipolar Disorder →
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.
Verify or expand the search:
- PubMed search for NCT06167577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06167577 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Last refreshed: 4 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06167577.
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