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Clinical Trials
Clinical Research at the Mood Institute: Precision. Innovation. Integrity.
Digital Innovation
At the Mood Institute, we deliver high-performance clinical trial execution grounded in real-world psychiatric expertise. As an active site investigator for multiple interventional studies in treatment-resistant depression (TRD)—including NCT06713616 and NCT06725277—Dr. Harding and her team bring a unique combination of operational excellence, deep therapeutic insight, diverse patient population and technological innovation to every clinical partnership.
A Proven Track Record in Interventional Psychiatry
Dr. Harding is a nationally recognized expert in treatment-resistant mood disorders and has performed over 4,000 interventional procedures, including IV ketamine, Spravato™ (esketamine), TMS, and ECT. Her private practice has been specifically designed to support advanced, protocol-driven psychiatric interventions, making it an ideal environment for industry-sponsored clinical trials focused on mood disorders, neuropsychiatric agents, and next-generation therapeutics.
Expertise-Driven Operations
Our clinical team is deeply experienced in psychiatric assessments, safety monitoring, and patient engagement—particularly in high-complexity TRD populations. Our clinicians understand the nuances of working with patients who have failed multiple lines of treatment, ensuring quality data collection and high retention rates throughout the trial lifecycle.
AI-Powered Protocol Support
To enhance compliance and reduce deviations, the Mood Institute integrates a custom-trained AI assistant that is fully embedded into our research operations. This AI agent is specifically trained on each study protocol, giving clinical coordinators and staff on-demand access to visit schedules, assessment tools, dosing parameters, inclusion/exclusion criteria, and safety alerts.
This technology reduces manual errors, minimizes missed assessments, and ensures protocol fidelity—creating a smoother sponsor experience and cleaner, more reliable data.
Advanced Infrastructure for Interventional Psychiatry
We’re not just a research site—we’re a functioning, interventional psychiatric clinic with:
- Secure and private dosing suites for ketamine and esketamine
- Staff trained in clinical trial best practices, regulatory compliance, emergency preparedness and adverse event management
- On-site diagnostic equipment and lab coordination
- Fully integrated EDC (electronic data capture) and eConsent platforms
- Innovative custom software and AI agents to increase productivity and enhance regulatory compliance
Rapid Startup & High Feasibility
Our experienced research staff ensures a streamlined IRB approval process, fast patient identification and enrollment, and efficient coordination with CROs and sponsors. Our established presence in the Northeast U.S. gives us access to a broad, diverse patient population eager to participate in innovative research.
Therapeutic Focus
- Treatment-Resistant Depression (TRD)
- Major Depressive Disorder (MDD)
- Ketamine/Esketamine Therapies
- Psychedelic-Adjacent Neuropsychiatry
- Real-World Use Studies in Interventional Psychiatry
Let’s Build the Future of Psychiatry—Together
Whether you’re a sponsor launching a Phase II/III trial or seeking real-world evidence in a post-marketing study, the Mood Institute offers data integrity, operational agility, and a forward-thinking team ready to deliver.
OUR SKILLS
Explore the project lifecycle and consider projects from a holistic perspective.
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Digital Innovation