A Single Ketamine Infusion Combined With Music for Suicidal Ideation

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Adults age 18-64

• DSM-IV diagnosis of depressive episode as determined by the Mini International neuropsychiatric Interview criteria, and Montgomery Asberg Depression Rating Scale ≥ 28

• Suicidal ideation at baseline as and positive suicidal ideation defined as Scale for Suicidal Ideation score ≥4.

• Diagnosis of Major depressive disorder, bipolar disorder, or substance induced mood disorder will be included.

Exclusion Criteria:

• Active psychotic symptoms

• Current manic episode

• Previous diagnosis of Schizophrenia or Schizoaffective disorder

• Previous diagnosis of Intellectual disability or Autism Spectrum Disorder

• Previous diagnosis of Major Neurocognitive Disorder

• History of ketamine abuse or dependence

• Hypersensitivity to esketamine, ketamine, or any of the excipients.

Uncontrolled clinically significant medical conditions such as:

• Respiratory illness requiring the use of oxygen

• Previously documented prolonged QTc interval

• Current Aneurysmal vascular disease

• Arteriovenous malformation

• Intracerebral hemorrhage

• Unstable cardiac disease including history of myocardial infarction

• Positive urine pregnancy test

• Previous treatment of depression with Ketamine or Esketamine