We propose adding a 2 year follow-up to a funded, randomized clinical trial evaluating the efficacy of and indications for 8 months of continuation phase cognitive therapy (C-CT), pharmacotherapy (fluoxetine; FLX), and pill placebo (PBO) in outpatients with recurrent major depressive disorder (MDD) who are at higher risk for relapse. This initial project period will allow comment in the comparative durability of effects after the first year of follow-up after all protocol treatment is discontinued. In addition, we will begin to accrue data to evaluate the durability of effects over two years of follow-up. The trial and follow-up will be conducted by investigators at the University of Texas Southwestern Medical Center and the University of Pittsburgh School of Medicine. """"""""Higher risk"""""""" is defined by incomplete remission during the final weeks of acute phase CT, while """"""""lower risk"""""""" is defined as complete and stable remission (i.e., 7 consecutive Hamilton Rating Scale for Depression scores <7). This trial has great public health significance because it will help identify when CT reduces the risk of relapse and recurrence in patients suffering from recurrent MDD, an illness with high morbidity and mortality. Patients with the highest risk for relapse can then be targeted for the most vigorous preventive treatment. This study is also the first to evaluate the continuation phase pharmacotherapy (FLX) after incomplete remission with acute phase CT. This contrast is important because many patients do not have adequate insurance coverage to support the full course of acute CT plus continuation phase CT. Further, the pharmacotherapy group will permit tests of mode-specific vs. nonspecific therapeutic activity. The follow-up is important because it will allow comment not only on C-CT's preventive effect on relapse (while patients receive it) but also on recurrence (after it is discontinued). In this application, we propose to enter an additional 159 male and female outpatients, aged 18-70 with DSM-IV unipolar, nonpsychotic, recurrent MDD to 16 or 20 sessions of acute phase CT in order to have sufficient power to compare effects over the first year of follow-up. Additional responders at higher risk for relapse will be randomized to 8 months of: (a) C-CT, (b) FLX, or (c) PBO and then followed for 2 years; lower risk patients will be followed for 32 months after acute phase CT. Dependent variables measure response, relapse, recurrence, remission, and recovery. Blind evaluations and survival analysis are planned.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
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Interventions Research Review Committee (ITV)
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Rudorfer, Matthew V
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University of Pittsburgh
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