Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Single Ketamine Infusion Combined With Music for Suicidal Ideation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658420
Recruitment Status : Not yet recruiting
First Posted : December 8, 2020
Last Update Posted : May 7, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
The University of Texas Health Science Center at Tyler

Brief 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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Depressive Episode Drug: Ketamine Hydrochloride Other: Music Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: All four groups will receive treatment as usual as defined above (potential approved hospitalization, medication, psychotherapy, outpatient referrals, suicide safety planning). A factorial design is being implemented to test four interventions. One group will receive IV ketamine 0.5mg/kg infused over forty minutes with one hour of pre-planned music will be compared to 3 other groups: One group will receive the same dose of ketamine without music, one group will one hour of music without ketamine, and one group will receive neither music nor ketamine. During the 4-week follow up interval, subjects from both groups will be contacted by phone for weekly assessment of depression, SI and quality of life.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Ketamine Infusion Combined With Music for Suicidal Ideation During a Depressive Episode: A Randomized Open Label Clinical Trial
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
One group will receive IV ketamine 0.5mg/kg infused over forty minutes
Drug: Ketamine Hydrochloride
Individuals in the ketamine group will receive ketamine 0.5 mg/kg infused over 40 minutes
Other Name: Ketamine

Experimental: Ketamine + Music
One group will receive IV ketamine 0.5mg/kg infused over forty minutes with one hour of pre-planned music
Drug: Ketamine Hydrochloride
Individuals in the ketamine group will receive ketamine 0.5 mg/kg infused over 40 minutes
Other Name: Ketamine

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


Experimental: Music
One hour of pre-planned music without ketamine
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


No Intervention: Treatment as usual
No music nor ketamine given



Primary Outcome Measures :
  1. Scale for Suicide Ideation (SSI) [ Time Frame: 4 weeks ]
    Clinician administered scale. Score range 0-38. Higher scores are indicative of increased suicidal ideation. The primary efficacy evaluation for each panel will be the change in SSI total score from baseline, prior to the first IV ketamine dose, to 4 weeks after IV ketamine treatment. 25 % reduction in score will be deemed treatment response, 50% reduction will be determined to be treatment remission.


Secondary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 weeks ]
    Clinician administered depression rating scale. Score range= 0-60, higher scores are indicative of more severe depression. 50% score reduction is defined as response, 25% or less improvement in MADRS will be considered a non response.

  2. World Health Organization Quality of life Scale (WHOQOL-BREF) [ Time Frame: 4 weeks ]
    Score range- 0-100. Quality of life at study entry and every week. Higher scores are indicative of higher quality of life

  3. Quick Inventory of Depressive Symptomatology (QIDS SR-16) [ Time Frame: 4 weeks ]
    Self report measure of depression. Range 1-27, with higher scores indicative of more severe depression

  4. Time of hospitalization [ Time Frame: 4 weeks ]
    Average days of hospitalization between treatment groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658420


Contacts
Layout table for location contacts
Contact: Richard Idell, MD 2816088348 richard.idell@uthct.edu
Contact: Connie Castleberry, RN 9038775455 connie.castleberry@uthct.edu

Locations
Layout table for location information
United States, Texas
UT Health East Texas
Tyler, Texas, United States, 75703
Contact: Richard Idell, MD    281-608-8348    richard.idell@uthct.edu   
Principal Investigator: Richard Idell, MD         
Sub-Investigator: Robert Creath, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at Tyler
National Institutes of Health (NIH)
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Richard Idell, MD University of Texas Health Science Center at Tyler
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier: NCT04658420    
Other Study ID Numbers: 2020-042
KL2TR003168 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action