Major Depressive Disorder (single or recurrent episode) MedDRA version: 9.1 Level: LLT Classification code 10004940 Term: Bipolar II disorder
Conditions
Interventions
Trade Name: PAROXETINA DOC
Pharmaceutical Form: Tablet
INN or Proposed INN: Paroxetine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: WELLBUTRIN*F
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients Inclusion criteria: Major Depressive Disorder (single or recurrent episode) Both sex Age range 18-65 years HAM-D ≥ 16 written informed consent Control group inclusion criteria: Both sex Age range 18-65 years written informed consent 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: Patients Exclusion criteria: major Depressive Disorder with psychotic features history of any other DSM-IV-TR Axis I or II disorders than depression cognitive impairment (MMSE  24), mental retardation or another condition that don?t allow patients to provide written informed consent alcohol or substance abuse and dependence comorbid neurological diseases major physical and/or surgical illness pregnant and nursing women current estroprogestinic and glucocorticoid treatment regular taking other psychotropic medications (except benzodiazepines that don?t seems to modify BDNF levels) current psychotherapy Control group exclusion criteria: history of any other DSM-IV-TR Axis I or II disorders than depression ognitive impairment (MMSE  24), mental retardation or another condition that don?t allow patients to provide written informed consent alcohol or substance abuse and dependence comorbid neurological diseases major physical and/or surgical illness pregnant and nursing women current estroprogestinic and glucocorticoid treatment regular taking other psychotropic medications (except benzodiazepines that don?t seems to modify BDNF levels) current psychotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aims of this study are: to confirm the presence of significant differences between BDNF serum and plasma levels in patients with Major Depressive Disorder (MDD) and control subjects, at baseline; to investigate possible variations of BDNF levels, in patients treated with paroxetine or bupropion at each endpoint;;Primary end point(s): Baseline (T0): recruitment of depressive and control subjects and collection of blood samples. At baseline we will determine the presence of statistical differences between plasmatic and serum BDNF levels of patients and controls. If this difference is significant, the study will continue.;Secondary Objective: to evaluate correlations among BDNF serum and plasma levels and the severity of depressive symptoms measured with Hamilton Depression Rating Scale (HDRS) and global levels of psychiatric symptomatology with Clinical Global Impression (CGI), at baseline (T0), during follow-up at 2 months (T1), 6 months (T2), and 6 months after treatment (T3). | — |
Countries
Italy
Outcome results
None listed