Efficacy and Safety of Intranasal Esketamine in Patients With Treatment-Resistant Depression and Comorbid Chronic Post-traumatic Stress Disorder: Open-Label Single-Arm Pilot Study
Maud Rothärmel, Cherifa Benosman, Wissam El-Hage, Caroline Berjamin, Diane Ribayrol, Olivier Guillin, Raphaël Gaillard, Lucie Berkovitch, Virginie Moulier
Frontiers in Psychiatry July 8, 2022 DOI: 10.3389/fpsyt.2022.865466 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label, single-arm, retrospective pilot study Longitudinal Peer reviewed |
|---|---|
| Sample size | 11 |
| Population | Patients with treatment-resistant major depressive disorder and comorbid post-traumatic stress disorder (9 women, 2 men; mean age 47.3 years) |
| Intervention | Intranasal esketamine |
| Dose | 56 or 84 mg |
| Duration | 6-month follow-up; twice weekly during the first month, once weekly during the second month, then once every 1 or 2 weeks |
| Measures | Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire 9 items, Global Assessment of Functioning (GAF), Clinical Global Impression-Suicide Scale (CGI-SS) |
| Topics | Depression Esketamine PTSD |
| Citations | 31 |
| Key points | Intranasal esketamine was associated with a significant drop in mean MADRS scores, from 38.6 at baseline to 18.2 after six months, with 7 of 11 patients responding and 3 in remission. The proportion of patients rated moderately to severely suicidal fell from 63.6% to 27.3% after one month. The authors suggest esketamine is likely to be a treatment of choice for this comorbid population. |
Abstract
Introduction: Major depressive disorder (MDD) is more likely to resist to usual treatment when it is associated with post-traumatic stress disorder (PTSD). Capitalizing on the effect of ketamine in both treatment-resistant depression (TRD) and PTSD, we conducted a study in order to assess the efficacy of intranasal (IN) Esketamine in patients having TRD with comorbid PTSD.
Materials and Methods: In this open-label, single arm, retrospective pilot study, 11 patients were treated with IN Esketamine (56 or 84 mg) with a longitudinal follow-up of 6 months. IN Esketamine was administered twice weekly during the first month, once weekly during the second month, and then once every 1 or 2 weeks. Patients were assessed with Montgomery-Åsberg Depression Rating Scale (MADRS), Patient Health Questionnaire 9 items, Global Assessment of Functioning (GAF), and Clinical Global Impression-Suicide Scale (CGI-SS).
Results: We included 9 women and 2 men (mean age 47.3 ± 11.1 years). The mean (SD) MADRS scores decreased significantly from 38.6 (6.4) at baseline to 18.2 (10.03) after 6 months of IN Esketamine; 7 patients were responders and 3 patients were in remission. The percentage of patients who were moderately to severely suicidal declined from 63.6% at baseline to 27.3% after 1 month of IN Esketamine sessions. No serious adverse reactions were observed.
Conclusion: This study reports the outcomes of 11 severely ill patients with comorbid TRD and PTSD after IN Esketamine treatment. Esketamine significantly improved depression symptoms, suggesting that it is likely to be a treatment of choice in this specific population.