BACKGROUND: We evaluated the comparative efficacy and safety of venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment. METHODS: In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive venlafaxine ER (75-300 mg/day; n = 821) or fluoxetine (20-60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind venlafaxine ER (n = 530) or fluoxetine (n = 185). In the acute phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score < or =12 or > or =50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score < or =7. In the continuation phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. RESULTS: At the acute treatment phase end point, response rates were 79% for both venlafaxine ER and fluoxetine; remission rates were 49% and 50% for venlafaxine ER and fluoxetine, respectively. In the continuation phase, response rates were 90% and 92%, and remission rates were 72% and 69% for venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the continuation phase were 52% and 58% for venlafaxine ER and fluoxetine, respectively. CONCLUSION:Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.
RCT Entities:
BACKGROUND: We evaluated the comparative efficacy and safety of venlafaxine extended release (ER) and fluoxetine in the acute and continuation phases of treatment. METHODS: In this multicenter, double-blind study, outpatients with recurrent unipolar major depression were randomly assigned to receive venlafaxine ER (75-300 mg/day; n = 821) or fluoxetine (20-60 mg/day; n = 275). After a 10-week acute treatment phase, responders entered a 6-month continuation phase of ongoing therapy with double-blind venlafaxine ER (n = 530) or fluoxetine (n = 185). In the acute phase, the primary outcome was response, defined as a 17-item Hamilton Depression Rating Scale (HDRS) score < or =12 or > or =50% decrease from baseline; the secondary outcome was remission, defined as a HDRS score < or =7. In the continuation phase, the primary outcome was the proportion of patients who sustained response or remission. Secondary measures included time to onset of sustained response or remission (i.e., meeting criteria at two or more consecutive visits), relapse rates, and quality-of-life measures. RESULTS: At the acute treatment phase end point, response rates were 79% for both venlafaxine ER and fluoxetine; remission rates were 49% and 50% for venlafaxine ER and fluoxetine, respectively. In the continuation phase, response rates were 90% and 92%, and remission rates were 72% and 69% for venlafaxine ER and fluoxetine, respectively. Rates of sustained remission at the end of the continuation phase were 52% and 58% for venlafaxine ER and fluoxetine, respectively. CONCLUSION:Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.
Authors: Boadie W Dunlop; Thomas Li; Susan G Kornstein; Edward S Friedman; Anthony J Rothschild; Ron Pedersen; Philip Ninan; Martin Keller; Madhukar H Trivedi Journal: J Psychiatr Res Date: 2010-06-02 Impact factor: 4.791
Authors: Roger S McIntyre; Ka Young Park; Candy W Y Law; Farah Sultan; Amanda Adams; Maria Teresa Lourenco; Aaron K S Lo; Joanna K Soczynska; Hanna Woldeyohannes; Mohammad Alsuwaidan; Jinju Yoon; Sidney H Kennedy Journal: CNS Drugs Date: 2010-09 Impact factor: 5.749
Authors: Boadie W Dunlop; Thomas Li; Susan G Kornstein; Edward S Friedman; Anthony J Rothschild; Ron Pedersen; Philip Ninan; Martin Keller Journal: Psychiatry Res Date: 2010-03-21 Impact factor: 3.222
Authors: Madhukar H Trivedi; David L Dunner; Susan G Kornstein; Michael E Thase; John M Zajecka; Anthony J Rothschild; Edward S Friedman; Richard C Shelton; Martin B Keller; James H Kocsis; Alan Gelenberg Journal: J Affect Disord Date: 2010-05-26 Impact factor: 4.839
Authors: Susan G Kornstein; James H Kocsis; Saeeduddin Ahmed; Michael Thase; Edward S Friedman; Boadie W Dunlop; Bing Yan; Ron Pedersen; Philip T Ninan; Thomas Li; Martin Keller Journal: Int Clin Psychopharmacol Date: 2008-11 Impact factor: 1.659
Authors: Anthony J Rothschild; Boadie W Dunlop; David L Dunner; Edward S Friedman; Alan Gelenberg; Peter Holland; James H Kocsis; Susan G Kornstein; Richard Shelton; Madhukar H Trivedi; John M Zajecka; Corey Goldstein; Michael E Thase; Ron Pedersen; Martin B Keller Journal: Psychopharmacol Bull Date: 2009