Major depressive disorder (MDD), Seasonal affective disorder (subtype of MDD) MedDRA version: 12.1 Level: LLT Classification code 10012378 Term: Depression
Conditions
Interventions
Trade Name: Valdoxan
Product Name: agomelatin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AGOMELATINE
CAS Number: 138112762
Current Sponsor code: Valdoxan-H-C-915-IA-03
Concentration
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects: • Female or male • Caucasian • Age 18-65 years • Blood pressure 2 on HDRS item 3). Study group 1 (healthy volunteers) • No intake of psychotropic drugs within the preceding month • Global seasonality score (GSS) lower than 6 • No personal or family history (parents and siblings) of affective disorders or relevant diseases, as defined by the investigator (according to MINI (Sheehan et al., 1998) Study group 2 (Patients with MDD including SAD) • Fulfilled criteria for a moderate or severe episode of recurrent major depressive disorder (296.32, 296.33) assessed with Structured Clinical Interview for the DSM-IV (SCID) (First et al., 1996). Furthermore patients with SAD must fulfill the criteria for the seasonal pattern specifier according to the DSM-IV-TR • Healthy defined as absence of relevant laboratory findings or disease other than MDD (including SAD) as defined by the investigator. • total Hamilton Depression Rating score (HDRS) of >12 Structured Interview Guide for the Hamilton Depression Rating Scale, (HDRS, 21 items, Hamilton, 1960) • No axis-I co morbidity (according to MINI) (Sheehan et al., 1998) • No intake of psychotropic drugs during the following timeframes before the first study day: - 1 week for most antidepressants (including herbal medication), zolpidem and zopiclone, systemic corticosteroids, ACTH, central alpha-adrenergic agonists, reserpine, methyldopa, exogenous melatonin, and opioides; - 2 weeks for nonselective MAO inhibitors, benzodiazepines, and buspirone; - 3 weeks for fluoxetine (if the duration of treatment had been longer than 7 days); - 4 weeks for lithium, antiepileptics, barbiturates, and antipsychotics; - 6 months for long-acting depot neuroleptics. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 2.5.3 Exclusion criteria • History of relevant diseases as defined by the investogator • Known affective disorder (healthy subjects only) • HIV or Hepatitis B/C positive virology • Any drug intake 1 week prior to the first study day (excluding hormonal contraceptives) • No stable intake of concomitant medication (other than psychotropic drugs) during 4 weeks prior to study day 1. • Presence of relevant illness within the last 3 weeks • Suspected non-compliance with study instructions and life-style requirements • Alcohol or drug abuse • Blood/Plasma donation within 4 weeks prior to the study day • Healthy subjects with a subsyndromal SAD or a “out of range” result in the Neuropsychological test • High risk of suicide or a previous suicide attempt within 6 months before the first study day (score >2 on HDRS item 3). • Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rhythmic 24hour mRNA expression of CLOCK genes, differences in transcript levels of CLOCK genes, differences in the genome-wide gene expression, assessed in mRNA from peripheral blood leucocytes. ;Secondary Objective: Patients with MDD will be post hoc stratified, based on the DSM-IV seasonal pattern specifier (gene expression profiles before and after agomelatine treatment will be compared between MDD and SAD) ;Primary end point(s): Differences in leucocyte gene expression between healthy subjects and patients before and after agomelatine treatment over 14 days including: • Rhythmic 24hour mRNA expression of CLOCK genes • Differences in transcript levels of specific CLOCK genes • Differences in the genome-wide gene expression | — |
Countries
Austria
Outcome results
None listed