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

• Conditions: Major Depressive Disorder; MedDRA version: 14.1Level: HLGTClassification code 10012375Term: Depressed mood disorders and disturbancesSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: HLTClassification code 10012401Term: Depressive disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005878-37-IT
• Lead Sponsor: ANGELINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-12
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Men and women outpatients >=18 years of age;major depressive disorder according to DSM-IV criteria;HAMD17 score >=18 at both screening and baseline visits;symptoms of depression for at least one month;legally capable to give their written informed consent;women of childbearing potential must agree not to start a pregnancy from the signature of the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 six months; clinically significant hepatic or renal diseases; myocardial infarction (within 6 months); positive present history of glaucoma; history of risk factors for Torsade de Pointes; clinically abnormal electrolytes values; concomitant treatment with drugs known for QT prolongation; QTcF values higher than 450 msec;resistant major depression; seizure events, alcohol or psychoactive substance abuse or addiction; acute risk of suicide (HAMD, criterion 3 with a value > 3); presence of any primary psychiatric disorder other than major depression; pregnancy, lactation; use of antipsychotic drugs; any anxiolytic or sedative hypnotic drug; any drugs with psychotropic effects; concomitant treatment with CYP3A4 inhibitors; hyperthyroidism, clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests; vulnerable subjects

Study & Design

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