Notice Number: NOT-MH-18-068
Key Dates
Release Date: October 24, 2018
Response Date: December 10, 2018
None
Issued by
National Institute of Mental Health (NIMH)
Purpose
This Request for Information (RFI) seeks input on current clinical experiences in the use of ketamine (and/or related compounds) to reduce and prevent suicide ideation and behavior. NIMH seeks to identify research gaps in the clinical applications of these treatments .
Background
Suicide is the 10th leading cause of death, with rates increasing over several decades for all age groups, even while rates of many other major causes of premature mortality have declined. Despite increasing numbers of effective psychosocial interventions for suicide ideation and prevention of repeat suicide attempts, rapid, effective treatment options for individuals with acute/emergent suicide risk are limited.
The off-label use of ketamine for severe, and/or treatment resistant depression is occurring despite a limited evidence base that describes approaches to appropriate patient selection (e.g., exclusion criteria), safety data, and the duration of treatment needed to maintain the reported acute and dramatic relief from depression and suicide ideation. A recent consensus statement on the Use of Ketamine in the Treatment of Mood Disorders by the American Psychiatric Association noted that there are no postmarketing surveillance data on the on safety and effectiveness of ketamine for any psychiatric indication.
NIMH has declared suicide prevention research as a high priority and through this RFI, NIMH is seeking information on clinical experience in the use of ketamine (and/or related compounds) to reduce suicide events (ideation, attempts, and acute crisis care such as emergency care visits), and prevent relapse, with or without treatment-resistant depression (TRD). Experience with treatment modalities (infusion, nasal spray, oral pill form) that utilize ketamine across a number of clinical contexts (emergency departments, outpatient settings, inpatient settings, rehab settings) are of interest.
Information Requested
There are key questions to be addressed to build the evidence base for ketamine as rapid treatment to reduce suicide risk. In particular NIMH is interested in the community’s experience that could inform research that examines appropriate suicide risk treatment groups, treatment protocols, approaches to gathering safety information (during and post treatment), and approaches to examining treatment effects. This RFI seeks information from the community about experiences in current practice for using ketamine to treat suicide risk in the following areas:
- Clinician team training for/in infusion administration (e.g., anesthesiology, psychiatry), health care setting environments (e.g., supportive and calm setting; cardiac monitoring), and understanding the responsible parties to support the patient if in an outpatient setting
- Clinical treatment indications (e.g., acute/emergent suicide risk per se; TRD [including definitions of TRD] plus suicide ideation; suicide risk plus PTSD, bipolar disorder, etc.)
- Clinical contraindications, including estimating rates of substance misuse that may be associated with treatment, and moderators that may be associated with later substance misuse
- Exclusions for treatment (e.g., history of psychosis; recent substance use disorder; medical conditions; current benzodiazepine use; age groups)
- Drug administration issues such as delivery (e.g., IV, oral, nasal), dosing, sequencing, duration
- Indicators of acute response such as self-reported increased energy, decreased depression and suicide ideation; objectively recorded physiological responses
- Approaches to defining non-responders, and strategies for initial non-responders
- Approaches to defining duration of response, and indicators of durability of response
- Continuation interventions that are offered after initial response, including adjunct medications and/or neurocognitive/psychosocial interventions
- Approaches for safety monitoring of side effects (hemodynamics; nausea; dissociation; muscular weakness; suicide ideation; extreme anxiety) at the time of drug administration
- Approaches for safety monitoring post drug administration, after acute and repeated treatments (e.g., how often and for how long)
Submitting a Response
All comments must be submitted via email as text or as an attached electronic document. Your responses should be addressed to: [email protected] by December 10, 2018. Please include the Notice number in the subject line. Response to this RFI is voluntary. Responders are free to address any or all of the categories listed above. The submitted information will be reviewed by the NIH staff.
This request is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government. The NIH does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.
The NIH will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI may be reflected in future funding opportunity announcements. The information provided will be analyzed and may be aggregated in presentations and reports. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
Inquiries
Please direct all inquiries to:
Jane Pearson, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3598
Email: [email protected]
and Human Services (HHS)
