A Single Ketamine Infusion Combined With Music for Suicidal Ideation

This open-label trial (n=200) investigates the efficacy of a single ketamine infusion combined with music for suicidal ideation (SI) during a depressive episode.

It’s conducted by The University of Texas Health Science Center at Tyler and aims to address the shortcomings of current treatments for suicidal ideation associated with major and bipolar depression.

Participants, aged 18-64, with a DSM-IV diagnosis of depressive episode and positive suicidal ideation, are included. Exclusion criteria involve active psychotic symptoms, current manic episode, and various medical conditions.

The trial compares the effects of ketamine alone, ketamine with music, music alone, and treatment as usual. The primary outcome measure is the Scale for Suicidal Ideation (SSI), with secondary outcomes including depression scores and quality of life measures. Recruitment started in July 2021, with a projected completion date of April 2023.

Trial Details

Suicidal ideation (SI) associated with major and bipolar depression is commonly seen in a wide range of clinical practice situations including the emergency room (ER). Current treatment regimens are often unsatisfactory. About a third of patients fail to respond to currently available therapy, and there are no currently FDA indicated rapid acting treatments for SI. Suboptimal outcomes have triggered the search for new, well-tolerated and more effective forms of treatment. Small clinical trials suggest that low dose (0.5mg/kg) ketamine is safe and effective for SI. We believe adding music during ketamine infusion may reduce anxiety and lead to more reduced SI based on available evidence. We are testing the hypothesis that a single infusion of ketamine combined with music enhances tolerability and improves outcomes in the treatment of SI when combined with treatment as usual in a factorial study design. One treatment with Ketamine + music will be compared to compared to one-time treatment with ketamine alone, music alone, or treatment as usual. 50 individuals with a depressive episode and suicidal ideation will receive intravenous (IV) ketamine 0.5mg/kg infused over 40 minutes once with 60 minutes of music, 50 individuals will receive IV ketamine without music, 50 subjects will receive 60 minutes of music once, and 50 patients will receive treatment as usual without ketamine or music. We anticipate that the ketamine + music group will have statistically significant indices of improvement in the primary outcome, suicidal ideation scores on the Scale for Suicidal Ideation (SSI) 4 weeks after the ketamine infusion. Secondary outcomes will include depression scores on the MontgomeryÅsberg Depression Rating Scale (MADRS) scale, adverse effects, and SSI scores at the end of 4 weeks. If, as we anticipate, the results indicate success of ketamine + music for SI, the work will identify new opportunities to more effectively manage patients with depression and suicidal ideation presenting to the ER.

NCT Number NCT04658420

Data attribution

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