Trazodone Once a Day in Major Depression Disorder
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|ClinicalTrials.gov Identifier: NCT02086929|
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : December 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Trazodone Drug: Venlafaxine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||364 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind Study Comparing the Efficacy and Safety of Trazodone OAD and Venlafaxine XR in the Treatment of Patients With Major Depressive Disorder.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
300 mg/day for 8 weeks (including 1 week 150 mg/day of dose-titration). After 3 and 5 weeks of treatment, non responders will have dose increases (in increments of 75 mg/day) till to reach the maximum of 450 mg/day.
Dosage form: capsule.
Active Comparator: Venlafaxine XR
75 mg/die for 8 weeks. After 3 and 5 weeks of treatment, non responders will have dose increases (in increments of 75 mg/day) till to reach the maximum of 225 mg/day.
Dosage form: capsule.
- Hamilton Depression Rating Scale (HAMD) score [ Time Frame: Day 56 ]Mean change from baseline (Day 0) in HAMD score at Day 56.
- Montgomery-Asberg Depression Rating Scale (MADRS) score [ Time Frame: Day 56 ]Mean change from baseline (Day 0) in MADRS score at Day 56.
- Clinical Global Impression (CGI) Severity of Illness score [ Time Frame: Day 56 ]CGI-Severity of Illness improvement at Day 56.
- Clinical Global Impression (CGI) Global improvement score [ Time Frame: Day 56 ]CGI-Global improvement at Day 56.
- Percentage of responders [ Time Frame: Day 56 ]Rate of patients with a 50% decrease with respect to baseline on the HAMD score at Day 56.
- Percentage of patients with remission [ Time Frame: Day 56 ]Rate of patients with a HAMD score <or= at Day 56.
- Safety profile of trazodone OAD compared to venlafaxine XR [ Time Frame: 11 weeks ]Safety and tolerability will be assessed through adverse events monitoring, physical examinations and monitoring of vital signs, body weight, clinical laboratory tests, ECG.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086929
|Principal Investigator:||Filippo Bogetto, MD||Department of Neuroscience University of Turin - Italy|