Michel A Paul1, Gary Gray, Marvin Lange. 1. Defence and Civil Institute of Environmental Medicine, North York, Ontario, Canada. paul@dicem.dnd.ca
Abstract
INTRODUCTION: Aircrew receiving treatment for depression are grounded during treatment and follow-up observation, generally amounting to at least 1 yr. Selective serotonin re-uptake inhibitors (SSRls) offer new treatment options for depression, of which sertraline (Zoloft) has the least imposing side-effect profile. There has been considerable interest in the possibility of returning aircrew to restricted flying duties once stablized on an SSRI with resolution of depression. This study was undertaken to determine whether or not sertraline effects psychomotor performance. METHOD: There were 19 volunteer non-depressed subjects (12 men and 7 women) who were assessed for psychomotor performance during placebo and sertraline treatment, in a double-blind cross-over protocol in counter-balanced order. Each treatment arm lasted 5 wk and involved ingesting one capsule each morning. The daily sertraline dose was 50 mg during week 1, 100 mg during week 2, and 150 mg during weeks 3, 4, and 5. Subjects completed a drug side-effect questionnaire and were tested on two psychomotor test batteries once per week, on the same weekday, at the same time of day throughout each 5-wk treatment period. RESULTS: There was no significant effect of sertraline on serial reaction time, logical reasoning, serial subtraction, or multitask performance. With respect to drug side effects, there was a main effect of drugs on "getting to sleep" (p < 0.002), "awakenings" (p < 0.007), "returning to sleep" (p < 0.001), "dry mouth" (p < 0.016), "nausea" (p < 0.001), "diarrhea" (p < 0.026), "tremors" (p < 0.005), and "sweating" (p < 0.016), as well as a drug x trials interaction for "drowsiness" (p < 0.012), "libido" (p < 0.039), and "difficulty with ejaculation" (p < 0.001). There was no effect of sertraline on dizziness. CONCLUSIONS: While we found some of the expected side effects due to sertraline, there was no effect on psychomotor performance. These findings support the possibility of selected use in aircrew and should be helpful in the ongoing aeromedical discussion about this evolving issue.
RCT Entities:
INTRODUCTION: Aircrew receiving treatment for depression are grounded during treatment and follow-up observation, generally amounting to at least 1 yr. Selective serotonin re-uptake inhibitors (SSRls) offer new treatment options for depression, of which sertraline (Zoloft) has the least imposing side-effect profile. There has been considerable interest in the possibility of returning aircrew to restricted flying duties once stablized on an SSRI with resolution of depression. This study was undertaken to determine whether or not sertraline effects psychomotor performance. METHOD: There were 19 volunteer non-depressed subjects (12 men and 7 women) who were assessed for psychomotor performance during placebo and sertraline treatment, in a double-blind cross-over protocol in counter-balanced order. Each treatment arm lasted 5 wk and involved ingesting one capsule each morning. The daily sertraline dose was 50 mg during week 1, 100 mg during week 2, and 150 mg during weeks 3, 4, and 5. Subjects completed a drug side-effect questionnaire and were tested on two psychomotor test batteries once per week, on the same weekday, at the same time of day throughout each 5-wk treatment period. RESULTS: There was no significant effect of sertraline on serial reaction time, logical reasoning, serial subtraction, or multitask performance. With respect to drug side effects, there was a main effect of drugs on "getting to sleep" (p < 0.002), "awakenings" (p < 0.007), "returning to sleep" (p < 0.001), "dry mouth" (p < 0.016), "nausea" (p < 0.001), "diarrhea" (p < 0.026), "tremors" (p < 0.005), and "sweating" (p < 0.016), as well as a drug x trials interaction for "drowsiness" (p < 0.012), "libido" (p < 0.039), and "difficulty with ejaculation" (p < 0.001). There was no effect of sertraline on dizziness. CONCLUSIONS: While we found some of the expected side effects due to sertraline, there was no effect on psychomotor performance. These findings support the possibility of selected use in aircrew and should be helpful in the ongoing aeromedical discussion about this evolving issue.
Authors: Ulla Knorr; Maj Vinberg; Anders Gade; Per Winkel; Christian Gluud; Jørn Wetterslev; Ulrik Gether; Lars Kessing Journal: Ther Adv Psychopharmacol Date: 2011-10