BRAIN DERIVED NEUROTROPHIC FACTOR AND MAJOR DEPRESSIVE DISORDER TREATMENT: CLINICAL PSYCHOLOGICAL AND PSYCHOPHARMACOTHERAPIC EVALUATIONS - ND

• Conditions: Major Depressive Disorder (single or recurrent episode); MedDRA version: 9.1Level: LLTClassification code 10004940Term: Bipolar II disorder

• Registration Number: EUCTR2008-008918-39-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients
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

Patients
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified