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Bipolar I DisorderNCT06558201

Open Label Extension Study of NCT06221852

A study testing Ketogenic diet in people with Bipolar I Disorder and Schizoaffective Disorder, run by Mclean Hospital at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is a 12-week open-label extension study for participants completing study NCT06221852. Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Ketogenic diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
28 Aug 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • McLean Hospital

    Belmont, Massachusetts, 02487

Other trials in United States

About this study

Official title: Open Label Extension Study of NCT06221852 of the Ketogenic Diet in Participants With First Episode Bipolar Disorder.

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

Read the detailed description

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.

Being tested
Ketogenic diet
Keywords
First episode psychosis, Ketogenic diet, Keto, Brain energy metabolism, Insulin resistance, Schizoaffective disorder, Bipolar disorder, Magnetic resonance spectroscopy (MRS), Redox, Creatine kinase
Medical subject headings
Psychotic Disorders, Insulin Resistance, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic dietOther

    Also called Keto diet

    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.

Study groups in NCT06558201
Study groupRoleWhat they receive
Ketogenic dietExperimentalParticipants 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.
Receives: Other: Ketogenic diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

  4. 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.

    Measured: 24 weeks

  5. 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.

    Measured: 24 weeks

  6. 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.

    Measured: 24 weeks

  7. 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.

    Measured: 24 weeks

Secondary outcomes (21)

  1. Change in body weight

    Change from baseline to week 24 in participant body weight in kilograms, as measured using a standing scale.

    Measured: 24 weeks

  2. Change in glycated hemoglobin (Hemoglobin A1c) level

    Change from baseline to week 24 in fasting Hemoglobin A1c level.

    Measured: 24 weeks

  3. Change in triglyceride levels

    Change from baseline to week 24 in fasting triglyceride levels.

    Measured: 24 weeks

  4. Change in low-density lipoprotein (LDL) levels

    Change from baseline to week 24 in fasting LDL levels

    Measured: 24 weeks

  5. Change in high-density lipoprotein (HDL) levels

    Change from baseline to week 24 in fasting HDL levels

    Measured: 24 weeks

  6. Change in high-sensitivity C-reactive protein (hs-CRP) levels

    Change from baseline to week 24 in fasting hs-CRP levels.

    Measured: 24 weeks

  7. Change in brain gamma-aminobutyric acid (GABA) concentration

    Change from baseline to week 24 in GABA concentration measured by proton magnetic resonance spectroscopy.

    Measured: 24 weeks

  8. Change in brain glutamate metabolite concentration

    Change from baseline to week 24 in glutamate metabolite concentration measured by proton magnetic resonance spectroscopy.

    Measured: 24 weeks

  9. Change in brain glutathione (GSH)

    Change from baseline to week 24 in brain GSH measured by proton magnetic resonance spectroscopy.

    Measured: 24 weeks

  10. Change in brain Phosphocreatine (PCr)

    Changes from baseline to week 24 in PCr concentration as measured by in vivo 31P-MRS.

    Measured: 24 weeks

  11. Change in brain pH

    Change from baseline to week 24 in pH as measured by in vivo 31P MRS

    Measured: 24 weeks

  12. Change in brain inorganic phosphate concentration

    Change from baseline to week 24 in inorganic phosphate (Pi) concentration as measured by in vivo 31P MRS.

    Measured: 24 weeks

  13. Change in adverse events

    Change from baseline to week 24 in adverse events.

    Measured: 24 weeks

  14. Change in anxiety symptoms

    Change from baseline to week 24 from baseline to week 12 in Hamilton Anxiety Rating Scale (HAM-A) total score. Scores range from 0 - 56; a higher score indicates a higher level of anxiety.

    Measured: 24 weeks

  15. Change in stress symptoms

    Change from baseline to week 24 in Depression Anxiety Stress Scales (DASS-42) Stress Subscale score. Scores range from 0-42; a higher score indicates a higher level of stress.

    Measured: 24 weeks

  16. Change in cognitive performance

    Change from baseline to week 24 in Matrics Consensus Cognitive Battery (MCCB) Total Score. Scores range from 0.00% - 100.00%; a higher score indicates higher cognition.

    Measured: 24 weeks

  17. Change in Global Functioning Scale (GFS) - Social and Role total score

    Change from baseline to week 24 in Global Functioning Scale (GFS) - Social and Role total score. Scores range from 6-60; a lower score indicates worse social and role functioning.

    Measured: 24 weeks

  18. Change in blood NAD/NADH+ ratio

    Change from baseline to week 24 in blood NAD/NADH+ ratio.

    Measured: 24 weeks

  19. Change in blood GSH/GSSH ratio

    Change from baseline to week 24 in blood GSH/GSSH ratio.

    Measured: 24 weeks

  20. Change in growth differentiation factor 15 (GDF15)

    Change from baseline to week 24 in blood and saliva GDF15 levels.

    Measured: 24 weeks

  21. Change in cell-free mitochondrial DNA (cf-mtDNA)

    Change from baseline to week 24 in blood and saliva cf-mtDNA levels.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study start28 Aug 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will have completed the 12-week randomized controlled trial (NCT06221852), and will follow the ketogenic diet in this open label extension.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06558201
Sponsor's protocol ID
2023P002849-2
Status last verified
Jun 2026
First submitted
14 Aug 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic diet in people with Bipolar I Disorder and Schizoaffective Disorder, run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) (time frame: 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06558201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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