|The following article is part of conference coverage from the 2018 American Psychiatric Association (APA) Annual Meeting in New York, New York. Psychiatry Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in psychiatry. Check back for the latest news from APA 2018.|
NEW YORK — Almost twice as many geriatric patients with treatment-resistant depression showed a 50% response when treated with intranasal esketamine in combination with oral antidepressants compared with those treated with intranasal placebo and oral antidepressants, according to data presented at the 2018 American Psychiatric Association (APA) Annual Meeting, held May 5-9, in New York, New York City.1 Results also show that intranasal esketamine in combination with oral antidepressants demonstrated significant reduction of depressive symptoms and improved overall severity of depressive illness and health-related quality of life and functioning at 4 weeks.2
Researchers conducted a post hoc analysis of a double-blind, flexibly dosed, multinational study (ClinicalTrials identifier: NCT02133005) including 70 geriatric patients with treatment-resistant depression. Participants were randomly assigned to receive intranasal esketamine 28 mg, 56 mg, or 84 mg or intranasal placebo in addition to a new oral antidepressant twice weekly for 4 weeks.
Response, defined as a 50% decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) baseline score, and remission, defined as a MADRS score ≤12, were assessed until 4 weeks. Researchers also included a primary efficacy end point, compared between the treatment groups, which was defined as the difference between the MADRS score at baseline and MADRS score after 4 weeks of treatment. Secondary efficacy measures were Clinical Global Impression of Severity, Sheehan Disability Scale, and Patient Health Questionnaire-9
Results showed that 26.7% of patients treated with intranasal esketamine had a response to treatment at 4 weeks compared with 14.7% of patients treated with intranasal placebo. In addition, 16.7% of patients treated with intranasal esketamine achieved remission at 4 weeks compared with 2.9% of patients treated with placebo.
Investigators observed statistically significant improvements in MADRS total score with intranasal esketamine vs intranasal placebo at the double-blind end point with the mixed effects model, using repeated measures analysis (least squares mean difference, −5.4; 1-sided P =.016). Results also showed improvements in severity of depressive illness as measured by the Clinical Global Impression of Severity (1-sided P =.005). In addition, differences in mean changes in Sheehan Disability Scale and Patient Health Questionnaire-9 were as follow: least squares mean difference, −7.6 (1-sided P =.004) and −4.4 (1-sided P =.006), respectively, at the double-blind end point.
The investigators note that the most common events for intranasal esketamine plus oral antidepressants were dysphoria, fatigue, headache, insomnia, nausea, abdominal discomfort, cough, dizziness, erythema, nasal congestion, urinary tract infection, and vomiting. They add that the incidence of adverse events in geriatric patients was similar to that observed in the overall study population.
“Safety results of geriatric patients from the US treatment environment were similar to those found for the younger population in the esketamine phase 3 study and in the phase 2 studies,” the researchers concluded.
Study supported by Janssen Scientific Affairs, LLC.
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- Starr HL, Alphs LD, Ochs-Ross R, et al. Clinical response, remission, and safety of intranasal esketamine in a US population of geriatric patients with treatment-resistant depression. Presented at: American Psychiatric Association (APA) 2018; May 5-9, 2018; New York City. Poster 51.
- Starr HL, Alphs LD, Ochs-Ross R, et al. Clinical efficacy and safety of intranasal esketamine in a US population of geriatric patients with treatment-resistant depression. Presented at: American Psychiatric Association (APA) 2018; May 5-9, 2018; New York City. Poster 52.