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

December 2, 2024 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

During the first visit, all subjects will sign informed consent and undergo a a clinical interview, in which clinical data will be collected. The demographic information will be transcribed into the electronic data collection form ("Electronic case report forms" - eCFR). The electronic data collection form should be completed at the time of the visit, so that it can objectively report the most recent observations. Each month recruited subjects will be administered specific scales (BPRS, YMRS, HAM-D, SES, GAF) validated in order to assess the psychopathological component. In addition, at the beginning of the study, a neuropsychological evaluation will be conducted to assess the cognitive status of the recruited patients. Therefore, neuropsychological tests will be administered. standardized (WAIS, BAC-A). In addition, neuropsychological assessments will be carried out as a follow-up (administration of the BAC-A) every 6 months, culminating in a follow-up of at least 12 months, to monitor the cognitive status of the subjects. Information obtained during the conduct of this clinical study is confidential and disclosure to third parties other than those indicated is strictly prohibited. The data collected (all information contained in original documents and certified copies or results clinical trials, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the study) will be archived in the file. The documents will be stored in a specific locked filing cabinet. The information collected will then be entered into a database, a management system (e.g., Microsoft Access). The data will be constantly backed up at the end of each week to prevent the loss of data that have been stored on the server. A server failure will cause delays in the execution phase of the analyses. The investigator must maintain all study records according to the guidelines on Good Clinical Practice (CGP) "International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)" and according to the record retention policies of the country in which the study. In accordance with the ICH/GCP guidelines, the investigator/institution will maintain all electronic resources and all original documents that support the data collected from each subject and all study documents (documents essential to the conduct of a study clinical trial). The investigator/institution will take measures to prevent the destruction accidental or premature destruction of these documents. Essential documents must be kept for at least 2 years after the end of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20100
        • Fondazione Irccs Ca' Granda - Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Bipolar disease patients who required therapy with an atypical antipsychotic in combination with a mood stabilizer

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Comorbidity with other psychiatric disorders;
  • comorbidity with neurological disorders, with damage to the brain and with deficits intellectual;
  • pregnancy;
  • current and past substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
analyze the impact of genetic variants of the Disbindin-1 gene on patient's response to antipsychotic drugs
Time Frame: 12 months
Patients will undergo a follow-up lasting at least 12 months, during which we will we will record: Number and duration of illness relapses (hypomanic/manic, mixed or depressive), the number of emergency room admissions, hospitalizations, attempted suicide; Assessment of clinical and psychopathological status by psychometric scales (BPRS, MRS, HAM-D, SES and GAF) every month; Assessment of cognitive status through neuropsychological tests standardized (WAIS, BAC-A) every 6 months; A single blood sample collection at study entry (TO) for the DTNBP1 gene genotyping (DysBray functional haplotype (12).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ASST Santi Paolo e Carlo
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Asst Melegnano e Martesana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DYSBIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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