A Single Ketamine Infusion Combined With Music for Suicidal Ideation
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center at Tyler
Collaborators:
National Institutes of Health (NIH) The University of Texas Health Science Center, Houston