Intranasal Racemic Ketamine Maintenance Therapy for Patients with Treatment-Resistant Depression: A Naturalistic Feasibility Study
Katelyn Halpape, Raelle Pashovitz, Annabelle Wanson, Monika Hooper, Evyn M Peters
Research Square preprint DOI: 10.21203/rs.3.rs-4125617/v1 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Observational program evaluation Pilot study |
|---|---|
| Sample size | 5 |
| Population | Adult inpatients with treatment-resistant depression who had been successfully treated with intranasal racemic ketamine in hospital |
| Intervention | Intranasal racemic ketamine spray |
| Dose | 220 mg (100 to 400 mg) |
| Duration | Up to 192 days |
| Topics | Depression Esketamine Ketamine |
| Key findings | Intranasal racemic ketamine maintenance therapy for treatment-resistant depression appeared feasible and well tolerated, with no serious adverse events and stable or improved depressive symptoms and quality of life. |
Abstract
Abstract Background Ketamine is a promising therapy for treatment-resistant depression due to its rapid onset, although benefits are often transitory, with patients needing maintenance therapy to prevent relapse. Most data supporting ketamine for treatment-resistant depression refers to the intravenous route of administration, leaving alternative routes lacking in data, especially as maintenance regimens. Moreover, the safety of ketamine maintenance therapy is poorly defined. This report aims to describe and evaluate a novel hospital-to-outpatient intranasal racemic ketamine maintenance therapy program.
Methods: This was an observational program evaluation study. Participants were adult inpatients with treatment-resistant depression who had been successfully treated with intranasal racemic ketamine in hospital and were being referred for outpatient maintenance therapy with an intranasal racemic ketamine spray, administered at a specialized community treatment centre. Effectiveness was assessed with the Self-Report Quick Inventory of Depressive Symptomatology, the Quality of Life Scale, and the Clinical Global Impression-Improvement scale.
Results: Five patients were enrolled, completing up to 14 treatment sessions over 192 days. The mean dose administered throughout treatment was 220 mg (100 to 400 mg). All patients benefited from ketamine as evidenced by decreased (or stable) depressive symptoms and increased (or stable) quality of life. There were no serious adverse events or discontinuations due to adverse effects. Reported adverse effects included anxiety and nausea. Slight blood pressure increases were seen during treatment, none of which required intervention.
Conclusions: Intranasal racemic ketamine maintenance therapy for treatment-resistant depression appeared to be feasible and well tolerated, although limited effectiveness conclusions can be drawn from this small pilot study. Further investigations regarding the safety and effectiveness of intranasal ketamine maintenance therapy are warranted.
Comparable studies
Other observational and cohort studies on ketamine for depression, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Concomitant BDNF and sleep slow wave changes indicate ketamine-induced plasticity in major depressive disorder Patients with treatment-resistant major depressive disorder | 2012 | Observational cohort | n = 30 |
| Altered peripheral immune profiles in treatment-resistant depression: response to ketamine and prediction of treatment outcome Healthy controls and actively depressed patients with treatment-resistant depression... | 2017 | Observational cohort | n = 59 |
| Clinical Predictors of Ketamine Response in Treatment-Resistant Major Depression Treatment-resistant inpatients with DSM-IV-TR-diagnosed major depressive disorder or... | 2014 | Post hoc analysis of pooled data from four studies | n = 108 |
| An investigation of amino-acid neurotransmitters as potential predictors of clinical improvement to ketamine in depression Drug-free patients with major depressive disorder | 2011 | Observational cohort | n = 14 |
| Efficacy of ketamine therapy in the treatment of depression Drug-free/naïve men with severe depression, no history of psychotic disorder, head... | 2019 | Observational cohort | n = 25 |