Suicidal ideation during treatment of depression with escitalopram and nortriptyline in genome-based therapeutic drugs for depression (GENDEP): a clinical trial

• Published in: BMC medicine 2009-10, Vol.7 (1), p.60-60, Article 60
• Main Authors: Perroud, Nader, Uher, Rudolf, Marusic, Andrej, Rietschel, Marcella, Mors, Ole, Henigsberg, Neven, Hauser, Joanna, Maier, Wolfgang, Souery, Daniel, Placentino, Anna, Szczepankiewicz, Aleksandra, Jorgensen, Lisbeth, Strohmaier, Jana, Zobel, Astrid, Giovannini, Caterina, Elkin, Amanda, Gunasinghe, Cerisse, Gray, Joanna, Campbell, Desmond, Gupta, Bhanu, Farmer, Anne E, McGuffin, Peter, Aitchison, Katherine J
• Format: Article
• Language: English
• Subjects: Acquisitions & mergers; Adolescent; Adult; Aged; Antidepressants; Antidepressive Agents, Tricyclic - adverse effects; Antidepressive Agents, Tricyclic - therapeutic use; Biomedical research; Citalopram - adverse effects; Citalopram - therapeutic use; Clinical trials; Complications and side effects; Data collection; Depression, Mental; Depressive Disorder - drug therapy; Dosage and administration; Drug therapy; Female; Gender differences; Genomes; Hospitals; Humans; Male; Management; Medical research; Mental health; Middle Aged; Nortriptyline; Nortriptyline - adverse effects; Nortriptyline - therapeutic use; Personality Inventory; Risk factors; Serotonin Uptake Inhibitors - adverse effects; Serotonin Uptake Inhibitors - therapeutic use; Suicidal ideation; Suicide - statistics & numerical data; Suicides & suicide attempts; Young Adult
• ISSN: 1741-7015; 1741-7015
• DOI: 10.1186/1741-7015-7-60

Suicidal thoughts and behaviours during antidepressant treatment, especially during the first weeks of treatment, have prompted warnings by regulatory bodies. The aim of the present study is to investigate the course and predictors of emergence and worsening of suicidal ideation during tricyclic antidepressant and serotonin reuptake inhibitor treatment. In a multicentre part-randomised open-label study, 811 adult patients with moderate to severe unipolar depression were allocated to flexible dosage of escitalopram or nortriptyline for 12 weeks. The suicidality items of three standard measures were integrated in a suicidal ideation score. Increases in this score were classified as treatment emergent suicidal ideation (TESI) or treatment worsening suicidal ideation (TWOSI) according to the absence or presence of suicidal ideation at baseline. Suicidal ideation decreased during antidepressant treatment. Rates of TESI and TWOSI peaked in the fifth week. Severity of depression predicted TESI and TWOSI. In men, nortriptyline was associated with a 9.8-fold and 2.4-fold increase in TESI and TWOSI compared to escitalopram, respectively. Retirement and history of suicide attempts predicted TWOSI. Increases in suicidal ideation were associated with depression severity and decreased during antidepressant treatment. In men, treatment with escitalopram is associated with lower risk of suicidal ideation compared to nortriptyline. Clinicians should remain alert to suicidal ideation beyond the initial weeks of antidepressant treatment. EudraCT (No.2004-001723-38) and ISRCTN (No. 03693000).