OBJECTIVE: We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. METHOD: After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥ 14 and a CGI-S score of ≥ 3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. RESULTS: For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e., lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. CONCLUSIONS: While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD.
RCT Entities:
OBJECTIVE: We investigated patient and disease characteristics predictive of relapse of MDD during a 52-week placebo controlled trial of selegiline transdermal system (STS) to identify patient characteristics relevant for STS treatment. METHOD: After 10 weeks of open-label stabilization with STS, 322 remitted patients with MDD were randomized to 52-weeks of double-blind treatment with STS (6 mg/24h) or placebo (PLB). Relapse was defined as Hamilton Depression Rating Scale (HAMD-17) score of ≥ 14 and a CGI-S score of ≥ 3 with at least 2-point increase from the beginning of the double blind phase on 2 consecutive visits. Cox's proportional hazards regression was used to examine the effect of potential predictors (age, sex, age at onset of first MDD, early response pattern, number of previous antidepressant trials, severity of index episode, number of previous episodes, melancholic features, atypical features and anxious feature) on outcome. Exploratory analyses examined additional clinical variables (medical history, other psychiatric history, and individual items of HAM-D 28) on relapse. RESULTS: For all predictor variables analyzed, treatment Hazard Ratio (HR=0.48~0.54) was significantly in favor of STS (i.e., lower relapse risk than PLB). Age of onset was significantly predictive of relapse. Type, duration, and severity of depressive episodes, previous antidepressant trials, or demographic variables did not predict relapse. In additional exploratory analysis, eating disorder history and suicidal ideation were significant predictors of relapse after controlling for the effect of treatment in individual predictor analysis. CONCLUSIONS: While age of onset, eating disorder history and suicidal ideation were significant predictors, the majority of clinical and demographic variables were not predictive of relapse. Given the post-hoc nature of analysis, the findings need confirmation from a prospective study. It appears that selegiline transdermal system was broadly effective in preventing relapse across different subtypes and symptoms clusters of MDD.
Authors: Nicolas Hoertel; Carlos Blanco; Maria A Oquendo; Melanie M Wall; Mark Olfson; Bruno Falissard; Silvia Franco; Hugo Peyre; Cédric Lemogne; Frédéric Limosin Journal: J Psychiatr Res Date: 2017-07-22 Impact factor: 4.791
Authors: Jack D Edinger; Rachel Manber; Daniel J Buysse; Andrew D Krystal; Michael E Thase; Phillip Gehrman; Christopher P Fairholme; James Luther; Stephen Wisniewski Journal: J Clin Sleep Med Date: 2017-02-15 Impact factor: 4.062
Authors: Danielle R Balzafiore; Natalie L Rasgon; Laura D Yuen; Saloni Shah; Hyun Kim; Kathryn C Goffin; Shefali Miller; Po W Wang; Terence A Ketter Journal: Int J Bipolar Disord Date: 2017-08-12
Authors: Patrick A Randall; Christie A Lee; Eric J Nunes; Samantha E Yohn; Victoria Nowak; Bilal Khan; Priya Shah; Saagar Pandit; V Kiran Vemuri; Alex Makriyannis; Younis Baqi; Christa E Müller; Merce Correa; John D Salamone Journal: PLoS One Date: 2014-06-17 Impact factor: 3.240