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

NCT02529462 | Completed Phase 3

• 1 other identifier: AB-GEN-2013
• Study Type: interventional
• Target: 521
• Locations: 1 country
• Sites: 12

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Sustained response to treatment

  The PGI-I scale (Patient Global Impression of Improvement) reports the patient's own assessment of improvement after the therapeutic interventions. It is a single-item questionnaire that assesses the change experienced using a 7-point Likert scale that runs from 1 (very much better) to 7 (very much worse). A sustained response will be considered when the patient reports a PGI-I score of 2 or less, on at least two consecutive assessments, maintained until the end of the follow-up.

  3 months

Secondary Outcomes (6)

• Response to treatment

  3 month

• Hamilton Rating Scale for Depression (HAM-D)

  3 months

• FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating)

  3 months

• Clinical Global Impression-Severity scale (CGI-S)

  3 months

• Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)

  3 months

Study Arms (2)

NEUROPHARMAGEN-Guided Treatment

EXPERIMENTAL

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.

Genetic: NEUROPHARMAGEN-Guided Treatment

Treatment As Usual

ACTIVE COMPARATOR

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

Drug: Treatment As Usual

Interventions

NEUROPHARMAGEN-Guided Treatment 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

Also known as: Supportive prescription information from Neuropharmagen test

NEUROPHARMAGEN-Guided Treatment

Treatment As Usual DRUG

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

Also known as: Usual practice

Treatment As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (12)

Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Consorci Sanitari del Maresme

Mataró, Barcelona, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08821, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Institut Pere Mata

Reus, Tarragona, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital de Mar

Barcelona, Spain

Location

Hospital de Jerez

Jerez de la Frontera, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Spain

Location

Related Publications (2)

• 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.

  PMID: 29728861 DERIVED

• 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.

  PMID: 28705252 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• José Manuel Menchón, MD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

• Víctor Pérez, MD

  Hospital del Mar in Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 5, 2024

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)