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Ketogenic diet for Schizoaffective Disorder

N/A
Waitlist Available
Led By Virginie-Anne Chouinard, MD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

This is a 12-week open-label extension study for participants completing study NCT06221852.

Eligible Conditions
  • Schizoaffective Disorder
  • Bipolar Disorder
  • Psychosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Clinical Global Impression (CGI) Scale
Change in brain creatine kinase forward reaction rate (kf)
Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)
+4 more
Secondary study objectives
Change in Global Functioning Scale (GFS) - Social and Role total score
Change in adverse events
Change in anxiety symptoms
+18 more
Other study objectives
Change in Extrapyramidal Symptom Rating Scale (ESRS) total score
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Change in World Health Organization Disability Assessment Schedule (WHODAS) score
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketogenic dietExperimental Treatment1 Intervention
Participants will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive diet counseling from a registered dietitian. Participants will be asked to monitor and report their blood ketone and glucose levels each day via a finger-prick device provided by the study team.

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
214 Previous Clinical Trials
21,661 Total Patients Enrolled
Baszucki Family FoundationUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Virginie-Anne Chouinard, MDPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
50 Total Patients Enrolled
~33 spots leftby Sep 2027
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