Change in neurocognitive functioning in patients with treatment-resistant depression with serial intravenous ketamine infusions: The Bio-K multicenter trial.

Journal: Psychiatry research

Volume: 335

Issue: 

Year of Publication: 

Affiliated Institutions:  Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA. Electronic address: singh.balwinder@mayo.edu. Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA. Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA. Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN, USA. Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA. Department of Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA. Pine Rest Christian Mental Health Services, Michigan State University, Grand Rapids, MI, USA. Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL, USA. Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.

Abstract summary 

This nonrandomized, multicenter, open-label clinical trial explored the impact of intravenous (IV) ketamine on cognitive function in adults (n = 74) with treatment-resistant depression (TRD). Patients received three IV ketamine infusions during the acute phase and, if remitted, four additional infusions in the continuation phase (Mayo site). Cognitive assessments using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) were conducted at baseline, end of the acute phase, and end of the continuation phase (Mayo site). Results showed a significant 53 % (39/74) remission rate in depression symptoms after the acute phase. In adjusted models, baseline language domain score was associated with a higher odd of remission (Odds Ratio, 1.09, 95 % CI = 1.03-1.17, p = 0.004) and greater improvement in MADRS at the end of the acute phase (β =-0.97; 95 % CI, -1.74 to -0.20; P = 0.02). The likelihood of remission was not significantly associated with baseline immediate or delayed memory, visuospatial/constructional, or attention scores. In the continuation phase, improvements in immediate and delayed memory and attention persisted, with additional gains in visuospatial and language domains. Limitations included an open-label design, potential practice effects, and ongoing psychotropic medication use. Overall, the study suggests cognitive improvement, not deterioration, associated with serial IV ketamine administrations for TRD. These findings encourage future studies with larger sample sizes and longer follow-up periods to examine any potential for deleterious effect with recurrent ketamine use for TRD. Trial Registration: ClinicalTrials.gov: NCT03156504.

Authors & Co-authors:  Singh Parikh Voort Pazdernik Achtyes Goes Yocum Nykamp Becerra Smart Greden Bobo Frye Burdick Ryan

Study Outcome 

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Statistics
Citations : 
Authors :  15
Identifiers
Doi : 10.1016/j.psychres.2024.115829
SSN : 1872-7123
Study Population
Male,Female
Mesh Terms
Other Terms
Ketamine;Neurocognition;Open-label study;RBANS;Treatment-resistant depression
Study Design
Study Approach
Country of Study
Publication Country
Ireland