A Single Ketamine Infusion Combined With Music for Suicidal Ideation

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.

Conditions

• Suicidal Ideation
• Depressive Episode

Interventions

DRUG

Ketamine Hydrochloride

Individuals in the ketamine group will receive ketamine 0.5 mg/kg infused over 40 minutes

OTHER

Music

A playlist by composer Nils Frahm will be played for 60 minutes. The music is instrumental, relaxing and subjectively thought to be uplifting by patients who have listened to the music during ketamine infusions performed previously by the PI for treatment of resistant depression. Music can be previewed at the link below: https://open.spotify.com/playlist/37i9dQZF1DWVbGPBkXJYHF

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• The University of Texas Health Science Center at Tyler

  lead OTHER

Principal Investigators

• Richard Idell, MD · University of Texas Health Science Center at Tyler

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2022-12-31

Completion

2023-04-30

FDA Drug

Yes

Countries

• United States

Study Locations