Summary of Clinical Studies
Moreover, we continue to rely on personalized medicine in psychiatry, relying on the ongoing clinical research on new pathologies.
You can learn about the results of trials below:”
Randomized, double-blind, controlled, naturalistic, multicentric, prospective clinical trial that enrolled 316 patients with major depressive disorder
The first large randomized controlled trial (RCT) with a pharmacogenetic-based decision support tool on patients with major depressive disorder, conducted in 18 hospitals in Spain.
Designed to evaluate the efficacy of Neuropharmagen® in the choice of drug treatment, measured by
the Patient Global Impression of Improvement scale (PGI-I).
Main Endpoint: The primary variable was the number of patients responding to treatment, which was defined as those who indicated that they felt “Moderately better” or “Much better” on the Patient Global Impression of Improvement scale (PGI-I). Secondary variables such as the Hamilton Depression Scale (HDRS-17) or the FIBSER (Frequency, Intensity, and Burden of Side Effects Ratings) were also analyzed to assess the tolerability of the treatment.
of adverse effects in 12 weeks
This is a reanalysis of clinical data obtained in the AB-GEN randomized clinical trial (post-hoc analysis) to evaluate the clinical utility of pharmacogenetic-guided therapy with Neuropharmagen® in specific patient subpopulations according to age, baseline severity and duration of the depressive episode.
Design: Prospective, double-blind, randomised clinical trial in patients with major depressive disorder (MDD). See AB-GEN study.
Main Endpoint: To investigate the impact of factors shown to influence antidepressant response (such as age, baseline severity and duration of the depressive episode) in the clinical utility of Neuropharmagen®. Endpoints considered were PGI-I response (score of ≤ 2), HDRS score change and HDRS response (change ≥ 50%).
Subjects: The study population was described in the main publication of the AB-GEN study results. In this reanalysis of data, the following patient subpopulations are studied: Age (< 60 years old; 60 years and older), baseline severity (baseline HDRS < 18; baseline HDRS ≥ 18; baseline HDRS ≥ 25); time from diagnosis (up to 1 year; up to 5 years; more than 5 years).
Results: PGx-guided treatment significantly improved response rates in non-aged patients compared to TAU (below 60 years old; same results were obtained with < 65 years cut-off), in subjects with moderate-to-severe depression, and in patients with diagnoses up to 1 and up to 5 years old. Subpopulations in the reanalysis were reasonably balanced regarding demographic and clinical characteristics, with an evenly distributed number of individuals between the PGx-guided and treatment-as-usual (TAU) arms.
PGI-I results according to patient age
(<60 years, p=0.015; >o=60 years, p=0.813)
PGI-I results according to main severity
(mild, HDRS < 18, p=0.638; moderate+severe, HDRS>o= 18, p=0.031)
PGI-I results according to time since diagnosis of MDD
(under 1 year, p=0.043; under 5 years, p=0.019; over 5 years, p=0.891)
Subjects: 191 patients with affective or psychotic disorders according to DSM-IV whose previous treatment had failed, with CGI-S ≥ 3 (92% had CGI-S ≥ 4) at baseline and having detailed information about their therapeutic regime were included in the analysis (see STROBE2007-compliant subject flow below).
Randomized, single-blind, controlled, multicentric, prospective clinical trial in 100 patients with major depressive disorder
- The first non-industry sponsored trial of a pharmacogenetic-based decision support tool for psychiatry in a cohort of Asian descent.
- Designed to evaluate the effectiveness and tolerability of Neuropharmagen®-guided treatment in Korean patients based on Hamilton Depression Rating Scale-17 (HDRS-17) score change and Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) score change, respectively.
Response rate (%) defined according to a 50% reduction in the HDRS-17.
Remission rate (%) defined as a HDRS-17 score < 7 after 8 weeks.
Rate of Patients with significant frequency, intensity, and burden of side effects (%) after 8 weeks, defined according to the Frequency, INtensity and Burden of Side Effects Rating (FIBSER) score of > 2
Fold increase in the odds of clinical response with Neuropharmagen®
Individual and pooled effect sizes for clinical response based on CGI-S score change
Prospective, observational, naturalistic study in 30 bipolar patients
Designed to examine the role of pharmacogenetic testing in the treatment of patients suffering from bipolar disorder comparing patients that received a therapeutic change consistent with PGx-testing with patients that maintained a therapy discordant with the test results based on clinical status using CGI-S, HDRS-21 and YMRS scales and adverse events recorded with the DOTES scale.
Evolution of severity was more favorable in patients whose therapy had been changed accordingly to the test results.
- A normalization in the number of adverse effects occurred in the group following the test recommendations.
Mirror cost analysis for 2 years of 30 bipolar patients
- Designed to evaluate the possible cost savings derived from the use of a pharmacogenetic test in bipolar patients.
- The comparison of costs before and after the change of therapy according to the recommendations of Neuropharmagen® resulted in cost savings in terms of number of hospitalizations, as well as the average duration of hospitalizations.
Design: Retrospective cohort study of children and adolescents with severe mental disorders who received treatment and underwent PGx testing. Proportion of patients achieving clinical improvement (CGI scale), amelioration of side effects (self-reported) and changes in the number of drugs prescribed were evaluated.
Subjects: 20 children and adolescents that underwent pharmacogenetic testing with Neuropharmagen® (10 living in residential foster care; and 10 who were not). 13 (65%) were on polypharmacy. All patients were 17 years or younger.
Results: Pharmacogenetic testing helped to improve the clinical outcome in virtually all children (95%, 19/20 children). Improvement (CGI-I) was 2 (0.79) (range 1-4): 2.1 (0.56) (range 1-3) in foster care children and 1.9 (0.99) (range 1-4) in non-foster care children. PGx testing helped reducing self-reported relevant side effects (p=0.006), the number of children on polypharmacy (from 65 to 45%) and the mean number of drugs per children (from 3.3 to 2.4 drugs, p=0.017).
Diag. < 1 year
CGI-S < 4
1st multicenter randomized clinical trial of commercial pharmacogenomic technology
CGI-S < 4
1st investigation of the effect of patient characteristics on pharmacogenomics
Without placebo control
CGI-I ≥ 3
Continuous Therapy > 6 wk
1st multicenter randomized clinical trial of commercial pharmacogenomic technology on representatives of non-European race
CGI-S < 3
Continuous therapy ≥ 3 mo
1st study of commercial pharmacogenomic technology
on bipolar disorder
Without control group
CGI-S < 4
1st study of commercial pharmacogenomic technology
by Viete (unpublished)
Taking medications for the treatment of adverse side reactions
Hospitalization < 15 d