research thesis proposal written and oral.

2.7 Study Timeline We will obtain the necessary regulatory approvals and finalize the standard operating procedures for all proposed protocols during the JIT pre-award period. This will allow us to immediately begin to recruit and enroll participants upon award activation. Participants will be recruited, enrolled, and tested on a rolling basis. We propose to test 7 adults with MDD, and 7 matched healthy non-depressed adults, every three months (see section 2.5 for detailed rationale of this goal). Importantly, if successful, this aggressive pace of recruitment and study enrollment is intended ensure that data are collected in 80 total study participants within 18 months. This strategy also provides buffering should we happen to unexpectedly fall short of quarterly recruitment goals and accounts for potential participant attrition/drop-out and experimental failures. Data collection, reduction, and analysis, along with appropriate safety monitoring, will be ongoing throughout the study. As such, we will be poised to continually submit abstracts for presentation at meetings of relevant professional societies (e.g., Society of Biological Psychiatry, American Physiological Society). This will serve as an additional metric by which to evaluate our progress toward enrollment goals. It is also anticipated that upon completion of this award, the PI will have generated substantial pilot data for the submission of a R01 proposal.

Pre- Award

Year 1 (04/21 – 03/22)

Year 2 (04/22 – 03/23)

Projected Timeline JIT Apr - Jun

Jul - Sep

Oct - Dec

Jan - Mar

Apr - Jun

Jul - Sep

Oct - Dec

Jan - Mar

IRB Approvals/Finalize Standard Operating Procedures

Participant Recruitment

Enrollment, n=14 (7 MDD)

Enrollment, n=28 (14 MDD)

Enrollment, n=42 (21 MDD)

Enrollment, n=56 (28 MDD)

Enrollment, n=70 (35 MDD)

Enrollment, n=80 (40 MDD)

Conduct Experiments

Data Analysis/Reduction

Abstract Submission

Manuscript Submission

Follow-up R01 Submission