Behavioural activation and trial‐based cognitive therapy may be beneficial to reduce suicidal ideation in major depressive disorder: A post hoc study from a clinical trial

Abstract Background Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). This study aimed to test the hypothesis that adjunctive brexpiprazole increases calmness and life engagement among patients with MDD, based on clinical trial exit interviews. Methods This was a pooled analysis of exit interview data from three exploratory, open-label studies of adjunctive brexpiprazole 1–3 mg/day. The studies enrolled 105 outpatients with MDD (DSM-IV-TR criteria), a current depressive episode, and inadequate response to antidepressant treatment during the current episode. Patients were interviewed if they completed the end-of-treatment visit (Week 6 or Week 12, depending on the study). Exit interviews took the form of semi-structured telephone interviews in which patients were asked mostly qualitative questions about their symptoms prior to the start of the study, and about improvements they had noted during treatment. Interview transcripts were reviewed and codes were assigned to calmness and life engagement vocabulary, allowing aggregation of the frequency of improvement in various domains. Results 79.8% (83/104) of patients described improvements consistent with at least one calmness term, most commonly feeling less anxious (46.2%) or less irritable (44.2%). A four-domain concept of patient life engagement was developed in which 88.6% (93/105) of patients described improvements consistent with at least one domain, specifically, emotional (77.1%), physical (75.2%), social (41.9%), and/or cognitive (36.2%). Of the patients who described improvement in calmness, 96.4% (80/83) also described improvement in life engagement. Conclusions Analysis of exit interview data suggests that patients were calmer and more engaged with life following treatment with adjunctive brexpiprazole. Thus, adjunctive brexpiprazole may provide a benefit on subjective patient outcomes in addition to the improvement in depressive symptoms shown by clinical rating scale data. Trial Registration: Data used in this post hoc analysis came from ClinicalTrials.gov identifiers: NCT02012218, NCT02013531, NCT02013609.

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Changes in Self-Schema Structure in Cognitive Therapy for Major Depressive Disorder: A Randomized Clinical Trial

Yearbook of Psychiatry and Applied Mental Health ◽

10.1016/s0084-3970(10)79323-3 ◽

2011 ◽

Vol 2011 ◽

pp. 67

Author(s):

J.L. Krupnick

Keyword(s):

Clinical Trial ◽

Major Depressive Disorder ◽

Depressive Disorder ◽

Cognitive Therapy ◽

Randomized Clinical Trial ◽

Major Depressive ◽

Self Schema ◽

Schema Structure

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Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials

CNS Spectrums ◽

10.1017/s109285291900097x ◽

2019 ◽

Vol 25 (3) ◽

pp. 352-362 ◽

Cited By ~ 1

Author(s):

Atul R. Mahableshwarkar ◽

John Affinito ◽

Elin Heldbo Reines ◽

Judith Xu ◽

George Nomikos ◽

...

Keyword(s):

Major Depressive Disorder ◽

Suicidal Ideation ◽

Depressive Disorder ◽

Short Term ◽

Open Label ◽

Major Depressive ◽

Increased Risk ◽

And Behavior ◽

Post Hoc

ObjectivesThis study aimed to evaluate the risk of suicidal ideation and behavior associated with vortioxetine treatment in adults with major depressive disorder (MDD).MethodsSuicide-related events were evaluated post hoc using 2 study pools: one short-term pool of 10 randomized, placebo-controlled studies (6–8 weeks) and another long-term pool that included 3 open-label extension studies (52 weeks). Evaluation of suicide-related events was performed using Columbia-Suicide Severity Rating Scale (C-SSRS) scores and treatment-emergent adverse events (TEAEs) data.ResultsAt baseline, the percentage of patients reporting any C-SSRS ideation or behavior events in short-term studies was similar between placebo (14.7%), vortioxetine (19.8%, 13.0%, 11.2%, and 13.7% for 5-, 10-, 15-, and 20-mg groups, respectively), and duloxetine active reference (13.2%) and did not change throughout the 6- to 8-week treatment period for placebo (17.0%), vortioxetine (19.3%, 13.5%, 12.6%, and 15% for 5-, 10-, 15-, and 20-mg groups, respectively), or duloxetine (11.3%). The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine. After 52-week treatment with vortioxetine, suicidal ideation based on C-SSRS was 9.8%, C-SSRS suicidal behavior was 0.2%, and the incidence of suicide-related events based on TEAEs was <1%. There were no completed suicides in any study.ConclusionsVortioxetine is not associated with increased risk of suicidal ideation or behavior in MDD patients.

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