The National Institute of Mental Health (NIMH) seeks clinical research applications that support the development of evidence-based treatment approaches for adult Attention-Deficit Hyperactivity Disorder (ADHD) that go beyond stimulant medications, utilizing nonstimulant medications, psychosocial interventions, and device-based treatments, sequentially or in combination, in situations where stimulant monotherapy is insufficiently effective, difficult to tolerate, or undesirable.
Donor Name: National Institute of Mental Health (NIMH)
State: All States
County: All Counties
Territory: Puerto Rico, Guam, U.S. Virgin Islands, American Samoa, and the Northern Mariana Islands
Type of Grant: Grant
Deadline: 10/25/2025
Size of the Grant: More than $1 million
Grant Duration: 5 Years
Details:
The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure.
Research Scope and Objectives
This notice of funding opportunity (NOFO) seeks applications for clinical research to adapt, optimize and test empirically-supported non-stimulant pharmacological, device-based, and/or psychosocial interventions to augment or replace stimulant medication in the treatment of ADHD in adults when stimulant monotherapy has proven clinically insufficient, undesirable (e.g., due to adverse effects or concern about tolerance or dependence), or unavailable. Proposed clinical trials may include multiple treatments used in combination or sequentially in a stepped-care design. Any non-stimulant intervention(s) – pharmacological, psychosocial, or device-based, as monotherapy or combined approaches – with evidence from the literature or pilot data, of efficacy in the treatment of adult ADHD, may be incorporated in the proposed treatment plan.
Consistent with the NIMH experimental therapeutics approach, this NOFO supports studies that not only test the intervention effects on outcomes of interest in real world settings, but also inform understanding of the intervention’s mechanisms of action. As such, applications must include an assessment of target engagement that includes (1) specified target mechanisms associated with the intervention, (2) measurement plans designed to assess the target mechanisms and mental health outcomes, and (3) analytic plans designed to evaluate both the intervention-induced changes in the target mechanisms and the associations between changes in the target mechanisms and the intervention outcomes. Any identified putative target should be evidence-based. Although formal pilot testing is not required, ideally, all steps in submitted applications would have been successfully undertaken by applicants with similar patients in a similar context, ranging from clinical assessment to treatment delivery to outcome measures, and appropriate control groups, conditions, and interventions must be defined. Valid and reliable instruments should be used to assess outcome measures, including changes in symptoms and functioning.
Representative research studies that would be responsive to this announcement include:
- A clinical trial to test the effectiveness of augmenting a partially effective stimulant medication with the addition of a nonstimulant medication, a psychosocial intervention, or a device-based treatment.
- A clinical trial to test the effectiveness of beginning treatment with a nonstimulant approach, e.g., in situations where the use of a stimulant is deemed undesirable.
- A clinical trial aimed at personalizing treatment of adults with ADHD plus substance use disorders or other specific comorbidities.
Potential Exploratory Research Goals:
- Assessment of potential moderators of treatment response, including age and other demographic and clinical characteristics.
- Optimal approaches to sustaining short-term clinical response during maintenance treatment.
Funding Information
- NIMH intends to commit $3,000,000.
- The maximum project period is 5 years.
Eligibility Criteria
Higher Education Institutions – Includes all types
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized).
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Organizations)
Foreign Organizations
- Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
For more information, visit Grants.gov.
