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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
NEUROPHARMAGEN-Guided Treatment
Treatment As Usual
Sponsored by
AB Biotics, SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Central de Asturias
  • Hospital Bellvitge
  • Consorci Sanitari del Maresme
  • Hospital Mutua de Terrassa
  • Institut Pere Mata
  • Hospital Clinic
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NEUROPHARMAGEN-Guided Treatment

Treatment As Usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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)
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)
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)
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)
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)
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.

Full Information

First Posted
August 19, 2015
Last Updated
December 2, 2016
Sponsor
AB Biotics, SA
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1. Study Identification

Unique Protocol Identification Number
NCT02529462
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Biotics, SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NEUROPHARMAGEN-Guided Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
In the control patient group, "treatment as usual" will be selected and prescribed in accordance with routine clinical practice .
Intervention Type
Genetic
Intervention Name(s)
NEUROPHARMAGEN-Guided Treatment
Other Intervention Name(s)
Supportive prescription information from Neuropharmagen test
Intervention Description
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
Drug
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
Usual practice
Intervention Description
Clinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test
Primary Outcome Measure Information:
Title
Sustained response to treatment
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Response to treatment
Description
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").
Time Frame
3 month
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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.
Time Frame
3 months
Title
FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating)
Description
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).
Time Frame
3 months
Title
Clinical Global Impression-Severity scale (CGI-S)
Description
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.
Time Frame
3 months
Title
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Description
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.
Time Frame
3 months
Title
Sheehan Disability Inventory (SDI)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Manuel Menchón, MD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Víctor Pérez, MD
Organizational Affiliation
Hospital del Mar in Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Consorci Sanitari del Maresme
City
Mataro
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Tarrasa
State/Province
Barcelona
Country
Spain
Facility Name
Institut Pere Mata
City
Reus
State/Province
Tarragona
Country
Spain
Facility Name
Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital de Mar
City
Barcelona
Country
Spain
Facility Name
Hospital de Jerez
City
Jerez
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29728861
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.
Results Reference
derived
PubMed Identifier
28705252
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.
Results Reference
derived

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

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