Efficacy and safety of trazodone OAD and venlafaxine XR in the treatment of Major Depressive Disorder

• Conditions: Major Depressive Disorder; MedDRA version: 16.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 16.1Level: HLGTClassification code 10012375Term: Depressed mood disorders and disturbancesSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 16.1Level: HLTClassification code 10012401Term: Depressive disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005878-37-CZ
• Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Outpatients; Men or women 18-75 years of age (limits included); diagnosis of MDD according to DSM-IV; HAMD -17 = 18 at screening and baseline visits; symptoms of depression for at least 1 month; patients legally capable to give their consent to participate the study, subjects must agree not to start a pregnancy from the signature of the informed consent (childbearing women).
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Use of venlafaxine or trazodone within the previous 6 months; liver or renal clinically significant disease; myocardial infarction (within 6 months); positive present history of glaucoma; risk factors for TdP; clinically significant electrolyte values; concomitant treatment with drugs known for QT prolongation; QTcF > 450msec; major depression resistant to medical treatments; seizure events; alcohol or psychoactive abuse or addiction; suicide risk (HAMD, criterion 3 value = 3); present history of psychiatric disorder rather than MDD; pregnant or lactating women; use of antipsychotic, anxiolytic or sedative hypnotic; use of drugs with psychotropic effect; treatment with CYP3A4 inhibitors; hyperthyroidism;clinically significant alterations at physical examination, vital signs, ECG and laboratory exams; vulnerable subjects.

Study & Design

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