Comparative efficacy and durability of continuation phase cognitive therapy for preventing recurrent depression: design of a double-blinded, fluoxetine- and pill placebo-controlled, randomized trial with 2-year follow-up.
BACKGROUND
Major Depressive Disorder (MDD) is highly prevalent and associated with disability and chronicity. Although cognitive therapy (CT) is an effective short-term treatment for MDD, a significant proportion of responders subsequently suffer relapses or recurrences.


OBJECTIVE
This design prospectively evaluates: 1) a method to discriminate CT-treated responders at lower vs. higher risk for relapse; and 2) the subsequent durability of 8-month continuation phase therapies in randomized higher risk responders followed for an additional 24 months. The primary prediction is: after protocol treatments are stopped, higher risk patients randomly assigned to continuation phase CT (C-CT) will have a lower risk of relapse/recurrence than those randomized to fluoxetine (FLX).


METHODS
Outpatients, aged 18 to 70 years, with recurrent MDD received 12-14 weeks of CT provided by 15 experienced therapists from two sites. Responders (i.e., no MDD and 17-item Hamilton Rating Scale for Depression <or=12) were stratified into higher and lower risk groups based on stability of remission during the last 6 weeks of CT. The lower risk group entered follow-up for 32 months; the higher risk group was randomized to 8 months of continuation phase therapy with either C-CT or clinical management plus either double-blinded FLX or pill placebo. Following the continuation phase, higher risk patients were followed by blinded evaluators for 24 months.


RESULTS
The trial began in 2000. Enrollment is complete (n=523). The follow-up continues.


CONCLUSIONS
The trial evaluates the preventive effects and durability of acute and continuation phase treatments in the largest known sample of CT responders collected worldwide.
Jarrett
Robin B
RB
Department of Psychiatry, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75390-9149, USA. Robin.Jarrett@UTSouthwestern.edu
Thase
Michael E
ME
D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy; D003865:Major Depressive Disorder / Q000517:prevention & control* / Q000628:therapy; D004311:Double-Blind Method; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D055502:Secondary Prevention; D055815:Young Adult
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine
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