Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients
|Depressive Disorder, Major||Genetic: NEUROPHARMAGEN-Guided Treatment Drug: Treatment As Usual||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomised, Controlled, Parallel Clinical Trial on the Efficacy of Pharmacogenetic Information Obtained With NEUROFARMAGEN in the Treatment of Patients With Mental Disorders|
- Sustained response to treatment [ Time Frame: 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.
- Response to treatment [ Time Frame: 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").
- Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 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.
- FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating) [ Time Frame: 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) [ Time Frame: 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.
- Treatment Satisfaction with Medicines Questionnaire (SATMED-Q) [ Time Frame: 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.
- Sheehan Disability Inventory (SDI) [ Time Frame: 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.
|Study Start Date:||July 2014|
|Study Completion Date:||October 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: 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.
Genetic: 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
Other Name: Supportive prescription information from Neuropharmagen test
Active Comparator: Treatment As Usual
In the control patient group, "treatment as usual" will be selected and prescribed in accordance with routine clinical practice .
Drug: 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
Other Name: Usual practice
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02529462
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain|
|L'Hospitalet de Llobregat, Barcelona, Spain|
|Consorci Sanitari del Maresme|
|Mataro, Barcelona, Spain|
|Hospital Mutua de Terrassa|
|Tarrasa, Barcelona, Spain|
|Institut Pere Mata|
|Reus, Tarragona, Spain|
|Hospital de la Santa Creu i Sant Pau|
|Hospital de Mar|
|Hospital de Jerez|
|Hospital 12 de Octubre|
|Hospital Ramon y Cajal|
|Complejo Hospitalario Universitario de Vigo|
|Principal Investigator:||José Manuel Menchón, MD||Hospital Universitari de Bellvitge|
|Principal Investigator:||Víctor Pérez, MD||Hospital del Mar in Barcelona|