Ignite Creation Date:
2024-05-06 @ 7:24 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02529462
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2015-08-19
Brief Title:
Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients
Sponsor:
AB Biotics SA
Organization:
AB Biotics SA
Study Overview
Official Title:
Randomised Controlled Parallel Clinical Trial on the Efficacy of Pharmacogenetic Information Obtained With NEUROFARMAGEN in the Treatment of Patients With Mental Disorders
Status:
COMPLETED
Status Verified Date:
2016-12
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:
This study evaluates the efficacy of NEUROPHARMAGEN pharmacogenetic test in the selection of the pharmacological treatments for patients with Major Depressive Disorder MDD both with and without psychiatric comorbidities Patients will be randomly asigned to test-guided treatment prescription or to treatment as usual ina a 11 ratio the results of the test will not be disclosed to the later until the end of the 3-month follow-up period The study will compare the rate of treatment responders among both groups based on patient-reported improvement collected by blind telephone interview
Detailed Description:
NEUROPHARMAGEN is a genetic test developed by AB-BIOTICS SA that enables the specific analysis of Single-Nucleotide Polymorphisms related to the pharmacokinetics and pharmacodynamics of different psychoactive drugs The aim of the test is to provide the psychiatrist with information that can help himher identify the most suitable medication for each patient
In the study group the psychiatrist will have the results of the NEUROPHARMAGEN test as supporting information to help himher select the best treatment for the patient In the control patient group the treatment will be selected and prescribed in accordance with routine clinical practice
This is a naturalistic double-blind randomized multicentric clinicaltrial carried out in Spain at psychiatry departments of several public hospitals The study aims to include a total of 520 patients with MDD including patient with significant psychiatric comorbidities such as anxiety or substance abuse
The study will compare groups based on the rate of treatment responders defined as a score of 2 or less ie Much betterVery much better in the Patient Global Impression of Improvement scale PGI-I This scale will be collected by blind telephone interviewers so as to have a double-blind assessment patient and interviewer
In the study group the psychiatrist will have the results of the NEUROPHARMAGEN test as supporting information to help himher select the best treatment for the patient In the control patient group the treatment will be selected and prescribed in accordance with routine clinical practice
This is a naturalistic double-blind randomized multicentric clinicaltrial carried out in Spain at psychiatry departments of several public hospitals The study aims to include a total of 520 patients with MDD including patient with significant psychiatric comorbidities such as anxiety or substance abuse
The study will compare groups based on the rate of treatment responders defined as a score of 2 or less ie Much betterVery much better in the Patient Global Impression of Improvement scale PGI-I This scale will be collected by blind telephone interviewers so as to have a double-blind assessment patient and interviewer
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