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Study details
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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

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Dietary Guidelines for Americans
  • 2.Ketogenic diet
Primary goalChange in depressive symptoms

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low10%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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