Clinical trial NCT02529462: Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients
Official title: Randomised, Controlled, Parallel Clinical Trial on the Efficacy of Pharmacogenetic Information Obtained With NEUROFARMAGEN in the Treatment of Patients With Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria at pre-randomization visit:

* 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

Exclusion Criteria at pre-randomization visit:

* 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).

Inclusion criteria at randomization visit:

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.

Primary outcomes:
measure: Sustained response to treatment
timeFrame: 3 months
Secondary outcomes:
measure: Response to treatment
timeFrame: 3 month
measure: Hamilton Rating Scale for Depression (HAM-D)
timeFrame: 3 months
measure: FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating)
timeFrame: 3 months
measure: Clinical Global Impression-Severity scale (CGI-S)
timeFrame: 3 months
measure: Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
timeFrame: 3 months
measure: Sheehan Disability Inventory (SDI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Bellvitge
state: Barcelona
city: Mataro
country: Spain
facility: Consorci Sanitari del Maresme
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Barcelona
city: Reus
country: Spain
facility: Institut Pere Mata
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital de Mar
city: Jerez
country: Spain
facility: Hospital de Jerez
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: José Manuel Menchón, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar in Barcelona
name: Víctor Pérez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.