Open Label Extension Study of NCT06221852
Launched by MCLEAN HOSPITAL · Aug 14, 2024
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
In this 12-week single arm open label extension study of NCT06221852, the investigators aim to assess the longer term efficacy, safety and tolerability of the ketogenic diet in participants completing the randomized study phase of NCT06221852. Investigators will assess longer term effects on energy metabolism, insulin resistance and psychiatric symptoms.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.
- Exclusion Criteria:
- • -No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.
About Mclean Hospital
McLean Hospital, a leading psychiatric affiliate of Harvard Medical School, is dedicated to advancing mental health care through innovative research and clinical trials. Renowned for its commitment to scientific excellence, McLean harnesses a multidisciplinary approach to address a wide range of psychiatric disorders, including depression, anxiety, and schizophrenia. With state-of-the-art facilities and a team of expert clinicians and researchers, the hospital aims to develop effective treatment strategies and improve patient outcomes. Its robust clinical trial program fosters collaboration and contributes to the broader understanding of mental health, ultimately enhancing therapeutic options for individuals in need.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Belmont, Massachusetts, United States
Patients applied
Trial Officials
Virginie-Anne Chouinard, MD
Principal Investigator
Mclean Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported