title: Treatment-emergent suicidal ideation during 4 months of acute management of unipolar major depression with SSRI pharmacotherapy or interpersonal psychotherapy in a randomized clinical trial.
abstract: BACKGROUND
  To date, few randomized controlled trials (RCTs) of major depression have examined suicidal ideation as an outcome measure. Our aim is to determine the incidence of treatment-emergent suicidal ideation (ESI) and behaviors during the acute phase of treatment with an SSRI antidepressant or interpersonal psychotherapy (IPT) in patients with unipolar major depression.
  
  
  METHODS
  In a two-site RCT, 291 adult outpatients with nonpsychotic major depression and a Hamilton Depression Rating Scale (HDRS) score ≥15 were randomly allocated to IPT or SSRI. Participants who did not remit with monotherapy received augmentation with the other treatment. ESI was defined as a post-baseline HDRS suicidality item score ≥2 or a post-baseline Quick Inventory of Depressive Symptomatology (QIDS) score ≥2 in patients with a baseline score ≤1.
  
  
  RESULTS
  Of the 231 participants who had no suicidal ideation at baseline, 32 (13.8%) subsequently exhibited ESI on at least one post-baseline visit. Time to suicidal ideation was significantly longer in patients allocated to SSRI compared to those allocated to IPT (HR = 2.21, 95% CI 1.04-4.66, P = .038), even after controlling for treatment augmentation, benzodiazepine use, and comorbidity with anxiety disorders. Worsening of suicidal ideation occurred in 7/60 patients who had suicidal ideation at baseline. In the large majority of cases, suicidal ideation was successfully managed with the study protocol.
  
  
  CONCLUSIONS
  In the context of careful monitoring and frequent contact, selective serotonin reuptake inhibitor (SSRI) was associated with a lower risk of ESI than IPT and both SSRI and IPT appeared to be safe treatments for patients with past suicide attempts, none of whom exhibited ESI during the study.
authors.affiliation: Department of Psychiatry, University of Pittsburgh School of Medicine, 3811 O’Hara Street, Pittsburgh, PA 15213, USA.
authors.forename: P
authors.initials: P
authors.lastname: Rucci
authors.forename: E
authors.initials: E
authors.lastname: Frank
authors.forename: P
authors.initials: P
authors.lastname: Scocco
authors.forename: S
authors.initials: S
authors.lastname: Calugi
authors.forename: M
authors.initials: M
authors.lastname: Miniati
authors.forename: A
authors.initials: A
authors.lastname: Fagiolini
authors.forename: G B
authors.initials: GB
authors.lastname: Cassano
mesh_terms: D000328:Adult; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use; D015283:Citalopram / Q000009:adverse effects* / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory / Q000706:statistics & numerical data; D011594:Psychometrics; D011613:Psychotherapy; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D059020:Suicidal Ideation
chemical_list: D001569:Benzodiazepines; D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors