Skip to content
Study details
Enrolling now

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Mclean Hospital
NCT IDNCT06221852ClinicalTrials.gov data as of Apr 2026
Target enrollment

50

Study length

about 3.8 years

Ages

18–45

Locations

1 site in MA

What this study is about

Researchers are testing whether a ketogenic diet, combined with usual treatment, can improve brain energy metabolism and psychiatric symptoms in people experiencing their first episode of bipolar disorder or schizoaffective disorder. The trial will last 1388 days and involve approximately 50 participants.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Dietary Guidelines for Americans
  • 2.Ketogenic diet

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized (Open Label)

You are randomly assigned, but you will know your treatment.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Endpoints

Primary: Change in depressive symptoms, Change in mania symptoms, Change in psychotic symptoms

Secondary: Change in adverse events, Change in anxiety symptoms, Change in body weight, Change in glycated hemoglobin (Hemoglobin A1c) level, Change in high-density lipoprotein (HDL) levels, Change in high-sensitivity C-reactive protein (hs-CRP) levels, Change in low-density lipoprotein (LDL) levels, Change in stress symptoms

Body systems

Psychiatry / Mental Health