Open Label Extension Study of NCT06221852

NCT06558201 | Enrolling By Invitation

• 1 other identifier: 2023P002849-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bipolar I Disorder; Schizoaffective Disorder; Psychosis

Keywords

First episode psychosis; Ketogenic diet; Keto; Brain energy metabolism; Insulin resistance; Schizoaffective disorder; Bipolar disorder; Magnetic resonance spectroscopy (MRS); Redox; Creatine kinase

Outcome Measures

Primary Outcomes (7)

• Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH)

  Change from baseline to week 24 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).

  24 weeks

• Change in brain creatine kinase forward reaction rate (kf)

  Change from baseline to week 24 in creatine kinase forward reaction rate (kf) as measured by 31P magnetization transfer (MT) MRS.

  24 weeks

• Change in insulin resistance

  Change from baseline to week 24 of insulin resistance measured using the homeostatic model assessment of insulin resistance (HOMA-IR) using fasting blood glucose and insulin levels.

  24 weeks

• Change in psychotic symptoms

  Change from baseline to week 24 in Positive and Negative Syndrome Scale (PANSS) total score. Scores range from 30-210; a higher score indicates a higher level of psychotic symptoms.

  24 weeks

• Change in depressive symptoms

  Change from baseline to week 24 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.

  24 weeks

• Change in mania symptoms

  Change from baseline to week 24 in Young Mania Rating Scale (YMRS) total score. Scores range from 0-60. A higher score indicates a more severe illness.

  24 weeks

• Change in Clinical Global Impression (CGI) Scale

  Change from baseline to week 24 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.

  24 weeks

Secondary Outcomes (21)

• Change in body weight

  24 weeks

• Change in glycated hemoglobin (Hemoglobin A1c) level

  24 weeks

• Change in triglyceride levels

  24 weeks

• Change in low-density lipoprotein (LDL) levels

  24 weeks

• Change in high-density lipoprotein (HDL) levels

  24 weeks

Other Outcomes (8)

• Change in World Health Organization Disability Assessment Schedule (WHODAS) score

  24 weeks

• Change in World Health Organization Quality of Life (WHOQOL) score

  24 weeks

• Change in Extrapyramidal Symptom Rating Scale (ESRS) total score

  24 weeks

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

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.

Other: Ketogenic diet

Interventions

Ketogenic diet OTHER

The ketogenic diet (KD) is a normo-caloric diet composed of high-fat, low carbohydrate, and adequate protein intake. The KD will consist of 3 meals a day plus snacks, targeting 75-80% fat, 13-18% protein, 7% carbohydrates.

Also known as: Keto diet

Ketogenic diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who met original entry criteria in, and completed, the randomized 12-week study of NCT06221852.

You may not qualify if:

• No longer meeting original entry criteria from the randomized 12-week study of NCT06221852.

Sponsors & Collaborators

• Mclean Hospital: lead
• Baszucki Family Foundation: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02487, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Insulin Resistance; Bipolar Disorder

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Virginie-Anne Chouinard, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will have completed the 12-week randomized controlled trial (NCT06221852), and will follow the ketogenic diet in this open label extension.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: August 28, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

US (1)