Major Depressive Disorder MedDRA version: 14.1 Level: HLGT Classification code 10012375 Term: Depressed mood disorders and disturbances System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: HLT Classification code 10012401 Term: Depressive disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Trazodone HCl containing Contramid® prolonged release tablets
Product Code: 039(C)
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: TRAZODONE HYDROCHLORIDE
CAS Number:
Sponsors
ANGELINI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy and safety of trazodone OAD vs 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 the final Visit.;Timepoint(s) of evaluation of this end point: at day 56 of treatment (final visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): mean change from baseline in MADRS score at the final visit; CGI-Severity of illness and CGI-Global improvement at the final visit; rate of responders defined as patients with a 50% decrease with respect to baseline on the HAMD score at the final visit; rate of patients with remission (HAMD score <=7) at the final visit;Timepoint(s) of evaluation of this end point: at day 56 of treatment (final visit) | — |
Countries
Austria, Czech Republic, Italy
Contacts
Public ContactClinical Trial Application Unit
ANGELINI ACRAF SpA
Outcome results
None listed