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Assessing the Impact of Ketamine-Assisted Multimodal Therapy on Depressive Symptoms: A Longitudinal Pre-Post BDI-II Study with Exploratory Follow-Up Analysis

Anja Frank, Mario H W Scheib

preprint DOI: 10.31219/osf.io/4smjr_v1 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Pre-post comparison Longitudinal
Sample size 67
Population Patients with varying primary diagnoses screened for depression at a Spanish clinic
Interventions Ketamine-assisted Psychotherapy repetitive Transcranial Magnetic Stimulation Neurofeedback additional psychotherapy sessions
Duration Not specified; follow-up assessments occurred over months and years
Topics Esketamine Ketamine
Key points A multimodal therapy including ketamine-assisted psychotherapy, rTMS, neurofeedback, and additional psychotherapy produced a large and significant reduction in depressive symptoms from pre- to post-treatment, with some patients maintaining gains for months or years.

Abstract

Introduction: Europe faces a worsening mental health crisis, with nearly half of the population (46%) reporting emotional or psychological issues, such as depression, within the last year. One in six Europeans is currently affected by mental health problems, equating to approximately 84 million individuals across the continent (Nawrocka, 2023).

Method: This study examines the impact of a multimodal therapeutic approach, including Ketamine-assisted Psychotherapy (KAP), repetitive Transcranial Magnetic Stimulation (rTMS), Neurofeedback, and additional psychotherapy sessions, on depressive symptoms as measured by the Beck Depression Inventory-II (BDI-II) in a Spanish clinic. Conducted in a clinical setting, the study involved patients with varying primary diagnoses (N = 67), all screened for depression.

Results: A pre-post comparison between baseline (T0) and post-treatment (T1) BDI-II scores revealed significant improvement (d=1.42; n=58), indicating the effectiveness of the multimodal therapy. Despite the small sample size of the long-term follow-up cohort (n = 28), the exploratory analysis offered valuable insights into the treatment’s sustained effects.

Conclusion: The significant reduction in depressive symptoms from pre- to post-treatment demonstrates the immediate efficacy of the intervention. Follow-up assessments suggest that these benefits can be sustained over months, with some patients maintaining improved outcomes even years after treatment.

Comparable studies

Other non-randomized and open-label trials on ketamine, most cited first.

Study Year Design Participants
Rapid Resolution of Suicidal Ideation After a Single Infusion of anN-Methyl-D-Aspartate Antagonist in Patients With Treatment-Resistant Major Depressive Disorder Subjects with DSM-IV-diagnosed treatment-resistant major depressive disorder 2010 Open-label trial n = 33
Intravenous arketamine for treatment-resistant depression: open-label pilot study Humans with treatment-resistant depression 2020 Open-label pilot trial n = 7
A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide. Hospitalized patients with Major Depressive Disorder and acute suicidal ideation and... 2024 Open label study n = 17
Ketamine Psychedelic Therapy (KPT): A Review of the Results of Ten Years of Research Alcoholic patients 1997 Controlled clinical trial n = 211
Ketamine Safety and Tolerability in Clinical Trials for Treatment-Resistant Depression Participants with DSM-IV-defined major depressive disorder and treatment-resistant... 2014 Pooled analysis of three clinical trials n = 97

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