Major Depressive Disorder MedDRA version: 11.1 Level: LLT Classification code 10057840 Term:
Conditions
Sponsors
Servier Slovensko, spol. s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographic characteristics - Aged 18 to 65 years (inclusive) - Male or female - Outpatients Diagnosis criteria - According to clinical examination in the phase of choice of the patients are verified following conditions: - Clinical diagnosis of depressive disorder verified according to MINI criteria (Mini International Neuropsychiatric Interview). Present episode can have moderate or serious intensity, with or without symptoms of melancholic subtype of depressive episode, without psychotic symptoms and the beginning of episode can not correlate with postpartum period. - MADRS score at least 20 - State, which demands the therapy with antidepressants - Patient is not treated with antidepressants at the time of involvement in the study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General criteria - Patients, which do not want to cooperate adequately or the patients in whom we can not expect sufficient compliance during the therapeutic period - Patients, which will not be available for examinations like it is defined in protocol (for example holidays, ...) • Pregnant or breastfeeding women • Women, which can potentially get pregnant and the adequate contraception is not provided (per oral contraception, intrauterine device or using of condoms) • Involvement in other study at he same time or in the period of three months before involvement in study, or it is known, that the patient is involved in another study at the time of choice of patients Medical and therapeutic criteria • Related to depression - All types of depression other than major depressive disorder, including Bipolar Disorder I and II, Double Depression (MDD combined with Dysthymic Disorder), chronic depressive disorder (defined as an episode of depression with a duration longer than 2 years), Schizoaffective Disorder of the depressive type, depression with psychotic features. - Dysthymic Disorder according to DSM IV criteria. - Current depressive episode having not responded to two different previous antidepressant treatments given for at least 4 weeks at an appropriate dose. - Marked suicidal intent and/or known suicidal tendencies for the current episode, based on item 10 of MADRS along with the investigator's opinion based on the patient’s medical history, previous suicide attempts, and quality of social and familial support. - Patient treated with electroconvulsive therapy within the last 3 months before inclusion or requiring electroconvulsive therapy at present (according to investigator’s judgment). - Insight-oriented and structured psychotherapy (interpersonal therapy, psychoanalysis, cognitive behavioral therapy) started within the 3 months before inclusion. - Light therapy received within 2 weeks before inclusion. • Related to other psychiatric conditions - Patients meeting DSM-IV diagnosis of current Panic Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder, acute Stress Disorder. - Patients with acute or chronic psychotic disorder. - Patients with antisocial, borderline, or histrionic personality disorders according to DSM IV criteria. - Patients with a severe personality disorder other than antisocial, borderline, or histrionic and prone to interfering with the evaluation of the study according to the investigator’s judgment. • Related to miscellaneous conditions - Alcohol or drug abuse or dependence within the past 12 months (excluding nicotine), as defined in DSM-IV. - Hepatic impairment. (i.e. cirrhosis or active liver disease) - ASAT, ALAT values > 2 times the upper reference value - Delirium or dementia according to DSM-IV. - Current diagnosis of neurological disorders: eg, stroke, seizures, migraine … - Severe or uncontrolled organic disease likely to interfere with the conduct of the study (eg, neoplastic, cardiovascular, pulmonary and digestive disorders, unstabilized diabetes of type I or II, untreated or uncontrolled arterial hypertension). - acute porphyria. - Shift workers. • Conditions related to previous or present therapy - All treatment listed below should be stopped before the inclusion in the study with respect of the corresponding wash-out period: - Antipsychotic drugs (including depot antipsychotic drugs, if they were administrated less then 2 months before involvement in study) - Thymoprophyl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this open study is to assess the efficacy of ValdoxanR in depressed patients. Montgomery-Åsberg Depression Rating Scale (MADRS) will be used for efficacy assessment. An 8-week treatment period in patients suffering from major depressive disorder will be evaluated. This evaluation will be made in the whole population and in sub-groups of patients receiving ValdoxanR in monotherapy or co-prescription of anxiolytics and/or hypnotics. ;Secondary Objective: The secondary objective is to evaluate efficacy of ValdoxanR on clinician-rated scales - namely the Clinical Global Impression (CGI) and Global Assessment of Functioning (GAF) scales. Another objective, set up during preparation of this trial, is to evaluate the impact of ValdoxanR on patients’ sleep and daytime functioning from the patient’s point of view. Screening of Sleep and Circadian Rhythms Disorders questionnaire (Circscreen) and the Sheehan Disability questionnaire scales will be used. ;Primary end point(s): The primary objective of this open study is to assess the efficacy of ValdoxanR in depressed patients. Montgomery-Åsberg Depression Rating Scale (MADRS) will be used for efficacy assessment. An 8-week treatment period in patients suffering from major depressive disorder will be evaluated. This evaluation will be made in the whole population and in sub-groups of patients receiving ValdoxanR in monotherapy or co-prescription of anxiolytics and/or hypnotics. | — |
Countries
Slovakia
Outcome results
None listed