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Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)

- Name of the grant: Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33 Clinical Trial Required)

- Description: This grant aims to support the early stage testing of pharmacologic interventions with novel mechanisms of action or device-based interventions for the treatment of mental disorders. The focus is on evaluating the clinical effect of the interventions and generating information about the underlying mechanisms. The grant encourages a protocol design that adequately tests the presumed mechanism of action of the intervention to provide meaningful information on the dose-dependent neurophysiological, clinical, and behavioral effects.

- Experimental therapeutics approach: Applicants must propose an experimental therapeutics approach for the development and testing of therapeutic interventions.

- Evaluation of clinical effect: Applicants must design studies that evaluate the clinical effect of the intervention.

- Generation of information about mechanisms: Applicants must design studies that generate information about the mechanisms underlying the mental disorder or intervention response.

- Pharmacologic interventions: The grant supports early stage testing of pharmacologic interventions with novel mechanisms of action.

- Device-based interventions: The grant also supports early stage testing of device-based interventions.

- Protocol design: Applicants must propose a protocol design that adequately tests the presumed mechanism of action of the intervention.

- Meaningful information: The grant aims to provide meaningful information where target modulation yields a dose-dependent neurophysiological, clinical, or behavioral effect.

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