Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04923204
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2021-05-03
Brief Title:
Utility of the Pharmacogenetic Information Provided by NEUROPHARMAGEN in the Treatment of Bipolar Depressionwith Bipolar Depression
Sponsor:
AB Biotics SA
Organization:
AB Biotics SA
Study Overview
Official Title:
Genetic Variations Associated With the Therapeutic Response and Profile of Adverse Effects in the Treatment of Bipolar Depression
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of the impact of the genetic variation of individual genes on the therapeutic response and side effects profile in a cohort of well-characterized patients with bipolar depression using NEUROPHARMAGEN
Detailed Description:
Bipolar disorder BD is a severe psychiatric condition characterized by mood swings between hypomania and depression with a total lifetime prevalence of 24 An early and effective therapeutic approach is key for the patient prognosis being the pharmacotherapy the main therapeutic tool for its management
Treatment guidelines for BD include a variety of psychotropic medications including lithium anticonvulsants antipsychotics antidepressants anxiolytics and combinations of these medications However treatment response is often inadequate and poor tolerability is frequently observed
Variability in treatment efficacy and tolerability has been shown to be influenced by several factors including the inherited genetic variation Several meta-analyses have shown that some genetic variants influence the probability of response to selective serotonin reuptake inhibitors SSRIs in patients with depression Similarly specific genetic polymorphisms have been associated with the risk of certain antipsychotic-induced adverse effects in patients with schizophrenia However the impact of many these variants has not been studied in the context of bipolar disorder
NEUROPHARMAGEN is a pharmacogenomic-based decision support tool that helps clinicians in the selection and dosing of psychoactive drugs based on the integration of pharmacogenetic information among other patients characteristics that influence the medication success
The clinical utility of NEUROPHARMAGEN has been evaluated in major depression disorder MDD through randomized clinical trials with hundreds of patients Two small pilot trials in bipolar patients have suggested a potential clinical utility of this tool in this patient population However the output of pharmacogenomic-based tools such as NEUROPHARMAGEN is based in the analysis of several genes which could differ in their individual clinical utility in a disorder-related manner
This observational retrospective epidemiological study includes 76 patients who attended the Bipolar Disorder Program of the Psychiatry Service of the Hospital Clinic de Barcelona Spain with the aim of objectively evaluate the impact of the genetic variation in individual genes on the therapeutic response and side effects profile in this cohort using NEUROPHARMAGEN
Treatment guidelines for BD include a variety of psychotropic medications including lithium anticonvulsants antipsychotics antidepressants anxiolytics and combinations of these medications However treatment response is often inadequate and poor tolerability is frequently observed
Variability in treatment efficacy and tolerability has been shown to be influenced by several factors including the inherited genetic variation Several meta-analyses have shown that some genetic variants influence the probability of response to selective serotonin reuptake inhibitors SSRIs in patients with depression Similarly specific genetic polymorphisms have been associated with the risk of certain antipsychotic-induced adverse effects in patients with schizophrenia However the impact of many these variants has not been studied in the context of bipolar disorder
NEUROPHARMAGEN is a pharmacogenomic-based decision support tool that helps clinicians in the selection and dosing of psychoactive drugs based on the integration of pharmacogenetic information among other patients characteristics that influence the medication success
The clinical utility of NEUROPHARMAGEN has been evaluated in major depression disorder MDD through randomized clinical trials with hundreds of patients Two small pilot trials in bipolar patients have suggested a potential clinical utility of this tool in this patient population However the output of pharmacogenomic-based tools such as NEUROPHARMAGEN is based in the analysis of several genes which could differ in their individual clinical utility in a disorder-related manner
This observational retrospective epidemiological study includes 76 patients who attended the Bipolar Disorder Program of the Psychiatry Service of the Hospital Clinic de Barcelona Spain with the aim of objectively evaluate the impact of the genetic variation in individual genes on the therapeutic response and side effects profile in this cohort using NEUROPHARMAGEN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None