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

Abstract：

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.

journal_name

Biol Psychiatry

journal_title

Biological psychiatry

authors

Keller MB,Trivedi MH,Thase ME,Shelton RC,Kornstein SG,Nemeroff CB,Friedman ES,Gelenberg AJ,Kocsis JH,Dunner DL,Dunlop BW,Hirschfeld RM,Rothschild AJ,Ferguson JM,Schatzberg AF,Zajecka JM,Pedersen R,Yan B,Ahmed S,Schm

doi

10.1016/j.biopsych.2007.04.040

subject

Has Abstract

pub_date

2007-12-15 00:00:00

pages

1371-9

issue

eissn

0006-3223

issn

1873-2402

pii

S0006-3223(07)00433-7

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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