TY - JOUR
T1 - Preventing depressive relapse and recurrence in higher-risk cognitive therapy responders
T2 - A randomized trial of continuation phase cognitive therapy, fluoxetine, or matched pill placebo
AU - Jarrett, Robin B.
AU - Minhajuddin, Abu
AU - Gershenfeld, Howard
AU - Friedman, Edward S.
AU - Thase, Michael E.
PY - 2013/11
Y1 - 2013/11
N2 - IMPORTANCE: Strategies to improve the course of recurrent major depressive disorder have great public health relevance. To reduce the risk of relapse/recurrence after acute phase cognitive therapy (CT), a continuation phase model of therapymay improve outcomes. OBJECTIVES: To test the efficacy of continuation phase CT (C-CT) and fluoxetine for relapse prevention in a pill placebo (PBO)-controlled randomized trial and compare the durability of prophylaxis after discontinuation of treatments. DESIGN: A sequential, 3-stage design with an acute phase (all patients received 12 weeks of CT); 8-month experimental phase (responders at higher risk were randomized to C-CT, fluoxetine, or PBO); and 24 months of longitudinal, posttreatment follow-up. SETTING: Two university-based specialty clinics. PATIENTS: A total of 523 adults with recurrent major depressive disorder began acute phase CT, of which 241 higher-risk responders were randomized and 181 subsequently entered the follow-up. INTERVENTIONS: Cognitive therapy responders at higher risk for relapse were randomized to receive 8 months of C-CT (n = 86), fluoxetine (n = 86), or PBO (n = 69). MAIN OUTCOMES AND MEASURES: Survival analyses of relapse/recurrence rates, as determined by blinded evaluators using DSM-IV criteria and the Longitudinal Interval Follow-up Evaluation. RESULTS: As predicted, the C-CT or fluoxetine groups were significantly less likely to relapse than the PBO group across 8 months. Relapse/recurrence rates for C-CT and fluoxetine were nearly identical during the 8 months of treatment, although C-CT patients were more likely to accept randomization, stayed in treatment longer, and attended more sessions than those in the fluoxetine and PBO groups. Contrary to prediction, relapse/recurrence rates following the discontinuation of C-CT and fluoxetine did not differ. CONCLUSIONS AND RELEVANCE: Relapse risk was reduced by both C-CT and fluoxetine in an enriched randomization sampling only CT responders. The preventive effects of C-CT were not significantly more durable than those of fluoxetine after treatment was stopped, suggesting that some higher-risk patients may require alternate longer-term interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00118404, NCT00183664, and NCT00218764.
AB - IMPORTANCE: Strategies to improve the course of recurrent major depressive disorder have great public health relevance. To reduce the risk of relapse/recurrence after acute phase cognitive therapy (CT), a continuation phase model of therapymay improve outcomes. OBJECTIVES: To test the efficacy of continuation phase CT (C-CT) and fluoxetine for relapse prevention in a pill placebo (PBO)-controlled randomized trial and compare the durability of prophylaxis after discontinuation of treatments. DESIGN: A sequential, 3-stage design with an acute phase (all patients received 12 weeks of CT); 8-month experimental phase (responders at higher risk were randomized to C-CT, fluoxetine, or PBO); and 24 months of longitudinal, posttreatment follow-up. SETTING: Two university-based specialty clinics. PATIENTS: A total of 523 adults with recurrent major depressive disorder began acute phase CT, of which 241 higher-risk responders were randomized and 181 subsequently entered the follow-up. INTERVENTIONS: Cognitive therapy responders at higher risk for relapse were randomized to receive 8 months of C-CT (n = 86), fluoxetine (n = 86), or PBO (n = 69). MAIN OUTCOMES AND MEASURES: Survival analyses of relapse/recurrence rates, as determined by blinded evaluators using DSM-IV criteria and the Longitudinal Interval Follow-up Evaluation. RESULTS: As predicted, the C-CT or fluoxetine groups were significantly less likely to relapse than the PBO group across 8 months. Relapse/recurrence rates for C-CT and fluoxetine were nearly identical during the 8 months of treatment, although C-CT patients were more likely to accept randomization, stayed in treatment longer, and attended more sessions than those in the fluoxetine and PBO groups. Contrary to prediction, relapse/recurrence rates following the discontinuation of C-CT and fluoxetine did not differ. CONCLUSIONS AND RELEVANCE: Relapse risk was reduced by both C-CT and fluoxetine in an enriched randomization sampling only CT responders. The preventive effects of C-CT were not significantly more durable than those of fluoxetine after treatment was stopped, suggesting that some higher-risk patients may require alternate longer-term interventions. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00118404, NCT00183664, and NCT00218764.
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U2 - 10.1001/jamapsychiatry.2013.1969
DO - 10.1001/jamapsychiatry.2013.1969
M3 - Article
C2 - 24005123
AN - SCOPUS:84888411589
SN - 2168-622X
VL - 70
SP - 1152
EP - 1160
JO - JAMA Psychiatry
JF - JAMA Psychiatry
IS - 11
ER -