Simpler Grants.gov #PAR-25-180

NIH Solicitation: Early Stage Clinical Trials for Novel Psychiatric Drugs and Devices

This opportunity from the National Institutes of Health (NIH) seeks applications for early stage clinical trials of novel drugs and neuromodulatory devices targeting psychiatric disorders. - Government Buyer: - National Institutes of Health (NIH), Mental Health Research Grants program - Products/Services Requested: - Milestone-driven clinical trials for investigational drugs and neuromodulatory devices - Focus on psychiatric disorders in both pediatric and adult populations - Includes first in human (FIH) and Phase II studies - Assessment areas: target engagement, pharmacological effects, safety, tolerability, feasibility - Early feasibility studies for novel devices to support rapid data collection - OEMs and Vendors: - No specific OEMs or vendors named - Collaboration encouraged between biomedical researchers and biotechnology/industry researchers - Unique/Notable Requirements: - Trials must be milestone-driven - Designed to facilitate further clinical development and FDA approval - Supports both drug and device innovation for psychiatric indications

Description

This Notice of Funding Opportunity (NOFO) supports early stage clinical trials of novel investigational drugs or neuromodulatory devices for psychiatric disorders in areas of unmet medical need. It funds milestone-driven trials in both pediatric and adult populations, including first in human and Phase II studies to assess target engagement, pharmacological effects, safety, and feasibility for further development. The NOFO also supports early feasibility studies of novel devices, aiming to facilitate rapid data collection to attract further funding for clinical development as FDA-approved treatments. Collaborative partnerships between biomedical and industry researchers are encouraged to advance psychiatric drug or device development.

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