Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients
- Conditions
- Depressive Disorder, Major
- Interventions
- Genetic: NEUROPHARMAGEN-Guided Treatment
- Registration Number
- NCT02529462
- Lead Sponsor
- AB Biotics, SA
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 521
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment As Usual Treatment As Usual In the control patient group, "treatment as usual" will be selected and prescribed in accordance with routine clinical practice . NEUROPHARMAGEN-Guided Treatment 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.
- Primary Outcome Measures
Name Time Method Sustained response to treatment 3 months 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.
- Secondary Outcome Measures
Name Time Method Sheehan Disability Inventory (SDI) 3 months SDI is a questionnaire that can be self-administered to measure the disability of patients with mental disorders. It has 3 sub-scales that are scored independently (disability - 3 items, stress - 1 item and perceived social support - 1 item). As each item is scored using a Likert scale from 0 to 10, the maximum possible score is 30.
Response to treatment 3 month 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 patient will be considered a responder when reporting a PGI-I score of 2 or less (i.e. "much better"/"very much better").
FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating) 3 months The scale consists of 3 questions with scores ranging from 0 (no side effects / no impairment) to 6 (intolerable / unable to function / present all of the time).
Clinical Global Impression-Severity scale (CGI-S) 3 months CGI-S is a descriptive scale that provides qualitative information on the severity of the patient's illness. It assesses the severity of the illness using a 7-point Likert scale that runs from 1 (not at all ill) to 7 (among the most extremely ill patients). In this study, both the self-rated (whereby the patient rates his/her own situation) and the doctor-rated versions will be administered so that the doctor can assess the severity of the condition.
Hamilton Rating Scale for Depression (HAM-D) 3 months HAM-D rates the clinical severity of depression. It has 17 questions, each with three to five possible answers, with scores ranging from 0 to 2 or from 0 to 4, respectively. The total score ranges from 0 to 52 and cut-off scores can be used to classify the depressive disorder.
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) 3 months It is a 17-item questionnaire and is a valid scale for any chronic or long-term condition. It is a self-administered questionnaire on treatment satisfaction and it assesses the following areas or dimensions: side effects; effectiveness of the medication; convenience of the medication; impact of the medication on everyday life; medical follow-up of the disease; and the patient's general opinion regarding his/her condition and the medication. All items are assessed using a 5-point Likert scale that runs from "no, not at all" with a value of 0 to "yes, very much" with a value of 4.
Trial Locations
- Locations (12)
Hospital Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Consorci Sanitari del Maresme
🇪🇸Mataro, Barcelona, Spain
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital de Jerez
🇪🇸Jerez, Spain
Hospital de Mar
🇪🇸Barcelona, Spain
Institut Pere Mata
🇪🇸Reus, Tarragona, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain