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

Phase 1

• Conditions: Major Depressive Disorder; MedDRA version: 19.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.0Level: HLGTClassification code 10012375Term: Depressed mood disorders and disturbancesSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 19.0Level: HLTClassification code 10012401Term: Depressive disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-04
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• 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

Primary Outcome Measures

Name	Time	Method
Main Objective: The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine extended release (venlafaxine XR) after an 8-week treatment period in patients with major depressive disorder. ;Secondary Objective: Not applicable;Primary end point(s): Mean change from baseline in HAMD score at final visit;Timepoint(s) of evaluation of this end point: Treatment day 56 (final visit)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mean change from baseline in MADRS score at final visit; CGI-Severity of illness and CGI-Global improvement at final visit; rate of responders defined as patients with a 50% decrease with respect to baseline on the HAMD score at final visit; rate of patients with remission (HAMD score = 7) at final visit.;Timepoint(s) of evaluation of this end point: Treatment day 56 (final visit)