The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) study: outcomes from the acute and continuation phases.
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.


CONCLUSIONS
Venlafaxine ER and fluoxetine were comparably effective during both acute and continuation phase therapy.
Keller
Martin B
MB
Brown University, Providence, Rhode Island 02906, USA. martin_keller@brown.edu
Trivedi
Madhukar H
MH
Thase
Michael E
ME
Shelton
Richard C
RC
Kornstein
Susan G
SG
Nemeroff
Charles B
CB
Friedman
Edward S
ES
Gelenberg
Alan J
AJ
Kocsis
James H
JH
Dunner
David L
DL
Dunlop
Boadie W
BW
Hirschfeld
Robert M
RM
Rothschild
Anthony J
AJ
Ferguson
James M
JM
Schatzberg
Alan F
AF
Zajecka
John M
JM
Pedersen
Ron
R
Yan
Bing
B
Ahmed
Saeeduddin
S
Schmidt
Michael
M
Ninan
Philip T
PT
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055502:Secondary Prevention; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride