Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients

NCT ID: NCT02529462

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 521 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-10-31

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 1:1 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 S.A. 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 him/her 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 him/her 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 (i.e. "Much better"/"Very 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).

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NEUROPHARMAGEN-Guided Treatment

In the study patient group, the psychiatrist will have the results of the NEUROPHARMAGEN genetic test as supporting information to help him/her select the best treatment for the patient.

Group Type: EXPERIMENTAL

NEUROPHARMAGEN-Guided Treatment

Intervention Type: GENETIC

NEUROPHARMAGEN is a pharmacogenetic test developed by AB-BIOTICS S.A. that enables the specific analysis of Single-Nucleotide Polymorphisms related to the pharmacokinetics and pharmacodynamics of multiple psychoactive drugs. In this arm, psychiatrists have access to the results of the NEUROPHARMAGEN test to support their medication choices

Treatment As Usual

In the control patient group, "treatment as usual" will be selected and prescribed in accordance with routine clinical practice .

Group Type: ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type: DRUG

Clinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test

Interventions

NEUROPHARMAGEN-Guided Treatment

NEUROPHARMAGEN is a pharmacogenetic test developed by AB-BIOTICS S.A. that enables the specific analysis of Single-Nucleotide Polymorphisms related to the pharmacokinetics and pharmacodynamics of multiple psychoactive drugs. In this arm, psychiatrists have access to the results of the NEUROPHARMAGEN test to support their medication choices

Intervention Type: GENETIC

Treatment As Usual

Clinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test

Intervention Type: DRUG

Other Intervention Names

Supportive prescription information from Neuropharmagen test; Usual practice

Eligibility Criteria

Inclusion Criteria

• Patients with diagnosed for major depressive disorder according to DSM-IV-TR criteria
• Patients who give their written informed consent to participate in the study. In the case of disabled patients, informed consent from the legal representative or responsible relative.
• Patients with a doctor-rated Clinical Global Impression - Severity Scale (CGI-S) score equal to or greater than 4.
• Patients who are diagnosed de novo who, in the doctor's opinion, require medication or are receiving treatment and require an antidepressant, antipsychotic or mood stabiliser as a replacement or additional medication

Patients who meet the screening criteria at the pre-randomisation visit must meet the following criteria at visit 1 to be randomised. Otherwise, they will be excluded from the active follow-up phase. The criteria are:

• Patients with a PGI-I score of 4 or more.
• Patients with a CGI score of 4 or more.
• Patients whose dose of pharmacological treatment, in the doctor's opinion, requires suppression, replacement, addition or modification with an antidepressant, antipsychotic or mood stabiliser.

Exclusion Criteria

• Patients who, in the investigator's opinion, will not be able to complete the study follow-up.
• Patients who are actively taking part in or who have taken part in another clinical trial in the past 3 months.
• Patients who are pregnant or breast-feeding, or patients who plan to become pregnant within the next 12 months.
• Patients who are or who require treatment with quinidine, cinacalcet and/or terbinafine (potent CYP2D6 inhibitors).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AB Biotics, SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Manuel Menchón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari de Bellvitge

Víctor Pérez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital del Mar in Barcelona

Locations

Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Institut Pere Mata

Reus, Tarragona, Spain

Hospital Clinic

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital de Mar

Barcelona, , Spain

Hospital de Jerez

Jerez de la Frontera, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Hospital Ramon y Cajal

Madrid, , Spain

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Countries

Spain

References

Menchon JM, Espadaler J, Tuson M, Saiz-Ruiz J, Bobes J, Vieta E, Alvarez E, Perez V. Patient characteristics driving clinical utility in psychiatric pharmacogenetics: a reanalysis from the AB-GEN multicentric trial. J Neural Transm (Vienna). 2019 Jan;126(1):95-99. doi: 10.1007/s00702-018-1879-z. Epub 2018 May 4.

Reference Type: DERIVED

PMID: 29728861 (View on PubMed)

Perez V, Salavert A, Espadaler J, Tuson M, Saiz-Ruiz J, Saez-Navarro C, Bobes J, Baca-Garcia E, Vieta E, Olivares JM, Rodriguez-Jimenez R, Villagran JM, Gascon J, Canete-Crespillo J, Sole M, Saiz PA, Ibanez A, de Diego-Adelino J; AB-GEN Collaborative Group; Menchon JM. Efficacy of prospective pharmacogenetic testing in the treatment of major depressive disorder: results of a randomized, double-blind clinical trial. BMC Psychiatry. 2017 Jul 14;17(1):250. doi: 10.1186/s12888-017-1412-1.

Reference Type: DERIVED

PMID: 28705252 (View on PubMed)

Other Identifiers

AB-GEN-2013

Identifier Type: -

Identifier Source: org_study_id