Major depressive disorder schizophrenia Bipolar disorder obsessive-compulsive disorder
Conditions
Interventions
Trade Name: NEUROFARMAGEN, genetic test
Product Name: NEUROFARMAGEN
Pharmaceutical Form: Mouthwash
Sponsors
AB-BIOTICS S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients of either sex over 18 years. - Patients with any of the following psychiatric diagnoses according to DSM-IV-TR: bipolar disorder, schizophrenia, major depressive disorder or obsessive-compulsive disorder - Patients who have given their written informed consent to participate in the study. In the case of disabled patients, informed consent of the legal representative or family member. - Patients with a value on the clinical global impression scale of severity (CGI-S) according to the doctor less than 4. - Patients who are newly diagnosed and that require medication or that are undergoing treatment and require a substitution or addition of medication with an antidepressant, antipsychotic or mood stabilizer. antidepresivo, antipsicótico o estabilizador del ánimo. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1800 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patients who are expected no to be able to complete the study. -Patients who are actively participating or have participated in the last three months in another clinical trial -Patients who are pregnant or breastfeeding, or patients who intend to become pregnant in the next 12 months. -Patients who are or require treatment with quinidine, cinacalcet and / or terbinafine (potent CYP2D6 inhibitors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess NEUROFARMAGEN test effectiveness in selecting drug treatments for mental disorders (major depressive disorder, bipolar disorder, schizophrenia and obsessive-compulsive disorder) by the proportion of patients achieving sustained response over a period of six months. Sustained response is considered when the patient gets a PGI-I of 2 points or less in two consecutive assessments after the last change in treatment.;Secondary Objective: Differences in the proportion of patients who discontinued treatment between groups Differences in tolerability between treatment groups. Changes in patient-perceived disability between groups. Differences in changes in the severity of the patient's disease by patient and investigator between groups. Differences in time to file a PGI-I of 2 or less points between groups. Differences in the clinical course of the patient according to specific scales of each of the diseases among groups Differences in satisfaction with treatment by patients Population Subgroup analysis of the primary and secondary listed above. Find new genetic markers predictive of good response or adverse effects to treatment Absolute cost savings involved in making Neurofarmagen Cost - effectiveness of Neurofarmagen;Primary end point(s): The primary endpoint of the study is to test the effectiveness of Neurofarmagen in the selection of pharmacological treatments for mental disorders (major depression, bipolar disorder, schizophrenia and obsessive-compulsive disorder) by the proportion of patients who obtained sustained response over a period of six months . The study will be performed by comparing the group of patients with access to test information at baseline and patients without access to this information until the end of follow up period. Sustained response in relation to diagnosed mental disorder will be evaluated over the 6-month follow-up study by the score on the PGI-I scale. It is considered that a patient has a sustained response wh | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Frequency of polymorphisms, through genetic test results Neurofarmagen. Tolerability through FIBSER scale modified in order to be valid for the 4 conditions under study. Likewise for tolerability study also be employed corresponding items SATMED Scale-Q. Satisfaction with treatment as SATMED-Q scale, by the change in the total score of the same. It will also examine the changes in the scores of the different dimensions of the scale. Study of disability under the SDI scale, describing the same total score and analyze developments along the track of the patient group and the comparison of the evolution of the two groups. Disease severity by the CGI-S, comparing initial and final values ??inter and intra groups. The Clinical Global Impression scale (CGI-S, Clinical Global Impression-Severity) is a descriptive scale that provides qualitative information on the severity of the clinical picture of the patient. In this study, both self-reported version administered as hetero version, in which the clinical severity will be evaluated by the doctor. Clinical course of the patient as specific scale for each condition under study. It will analyze the evolution from baseline visit to follow-up within the same group as well as a comparative between the groups. GWAS, polymorphisms analyzed results regarding the efficacy and safety of treatments for the whole study population (randomized patients baseline visit and follow-up patients without active) About pharmacoeconomic study. It will consider whether the decision to use Neurofarmagen implies economic benefits to the healthcare system. There will be a study of direct and indirect costs of all randomized patients. In the direct costs will consider the following items: direct cost of drug treatment, cost of any revenue in emergency shelters or centers, visits or checkups. In the indirect costs are only considered: lost work time (if applicable). The average economic cost per patient of each group of patients | — |
Countries
Spain
Contacts
Public ContactAriana Salavert
AB-BIOTICS
Outcome results
None listed