Depressive Disorder, MajorPhase 3NCT02529462
Trial to Evaluate Efficacy of Pharmacogenetic Information Obtained With NEUROPHARMAGEN in Treatment of MDD Patients
A Phase 3 study testing NEUROPHARMAGEN-Guided Treatment and Treatment As Usual in people with Depressive Disorder, Major, run by AB Biotics, SA at 12 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- NEUROPHARMAGEN-Guided Treatment and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- 12 sitesSpain
- Study dates
- Jul 2014to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Clinic
Barcelona
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital de Mar
Barcelona
Hospital de Jerez
Jerez de la Frontera
Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital 12 de Octubre
Madrid
Hospital Ramon y Cajal
Madrid
Consorci Sanitari del Maresme
Mataró, Barcelona
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Institut Pere Mata
Reus, Tarragona
Hospital Mutua de Terrassa
Terrassa, Barcelona, 08821
Complejo Hospitalario Universitario de Vigo
Vigo
About this study
Official title: Randomised, Controlled, Parallel Clinical Trial on the Efficacy of Pharmacogenetic Information Obtained With NEUROFARMAGEN in the Treatment of Patients With Mental Disorders
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.
Read the 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).
- Conditions
- Depressive Disorder, Major
- Being tested
- NEUROPHARMAGEN-Guided Treatment, Treatment As Usual
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROPHARMAGEN-Guided TreatmentGenetic
Also called Supportive prescription information from Neuropharmagen test
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 called Usual practice
Clinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Drug: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (6)
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").
Measured: 3 month
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.
Measured: 3 months
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Manuel Menchón, MD, Principal investigator, Hospital Universitari de BellvitgeVíctor Pérez, MD, Principal investigator, Hospital del Mar in Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529462
- Sponsor's protocol ID
- AB-GEN-2013
- Status last verified
- Dec 2016
- First submitted
- 19 Aug 2015
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29728861Perez 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.
PubMed 28705252
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled, Parallel Clinical Trial on the Efficacy of Pharmacogenetic Information Obtained With NEUROFARMAGEN in the Treatment of Patients With Mental Disorders
- ClinicalTrials.gov ID
- NCT02529462
- Acronym / sponsor ID
- AB-GEN-2013
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEUROPHARMAGEN-Guided Treatment | Experimental | Genetic: NEUROPHARMAGEN-Guided TreatmentIn 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. |
| Treatment As Usual | Active comparator | Drug: Treatment As UsualIn the control patient group, "treatment as usual" will be selected and prescribed in accordance with routine clinical practice . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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:
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEUROPHARMAGEN-Guided TreatmentAlso: Supportive prescription information from Neuropharmagen testNEUROPHARMAGEN 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 | Genetic | NEUROPHARMAGEN-Guided Treatment |
| Treatment As UsualAlso: Usual practiceClinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test | Drug | Treatment As Usual |
Primary outcome
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.
6 secondary outcomes
Response to treatment
Time frame: 3 month
Hamilton Rating Scale for Depression (HAM-D)
Time frame: 3 months
FIBSER Scale (Frequency, Intensity and Burden of Side Effects Rating)
Time frame: 3 months
Clinical Global Impression-Severity scale (CGI-S)
Time frame: 3 months
Treatment Satisfaction with Medicines Questionnaire (SATMED-Q)
Time frame: 3 months
Sheehan Disability Inventory (SDI)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Derived from this study: PubMed 29728861Menchon 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.
- Derived from this study: PubMed 28705252Perez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Manuel Menchón, MD principal investigator
Hospital Universitari de Bellvitge
Víctor Pérez, MD principal investigator
Hospital del Mar in Barcelona
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NEUROPHARMAGEN-Guided Treatment and Treatment As Usual in people with Depressive Disorder, Major, run by AB Biotics, SA at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained response to treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02529462, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.