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NCT06221852 · ClinicalTrials.gov registry record · NA
Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder
A NA study of Schizoaffective Disorder and Psychosis, sponsored by Mclean Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06221852: Recruiting NA study of Schizoaffective Disorder and Psychosis, sponsored by Mclean Hospital.
NCT06221852 is a NA study of Schizoaffective Disorder and Psychosis that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 50 participants, below the 172-participant average among 103 other Schizoaffective Disorder trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06221852, a NA study of Schizoaffective Disorder and Psychosis, is actively recruiting participants, sponsored by Mclean Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
Primary Outcome
Change from baseline to week 12 in NAD+/NADH as measured by in vivo phosphorus magnetic resonance spectroscopy (31P-MRS).
Conditions Studied
Interventions
- OTHER Ketogenic diet
- OTHER Dietary Guidelines for Americans
Study Locations (1)
Massachusetts
- McLean Hospital - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-03-12 |
| Est. Completion | 2027-12-30 |
| Phase | NA |
What NCT06221852 shows while recruiting
NCT06221852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 172-participant average among 103 other Schizoaffective Disorder trials with a reported enrollment target (71% lower).
The record links to 3 conditions, with Schizoaffective Disorder appearing as the primary indexed condition, and to 2 interventions - of which Ketogenic diet is the first listed.
NCT06221852 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06221852 about?
NCT06221852 is a clinical study titled "Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder". This is a randomized, controlled clinical trial to assess the effects of the ketogenic diet in combination with treatment as usual on brain energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder.
What is the current status of trial NCT06221852?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2024-03-12. Estimated completion is 2027-12-30.
What conditions does trial NCT06221852 study?
This clinical trial studies the following conditions: Schizoaffective Disorder, Psychosis, Bipolar I Disorder.
What interventions are being tested in trial NCT06221852?
The interventions under investigation include: Ketogenic diet (OTHER), Dietary Guidelines for Americans (OTHER).
Who is sponsoring clinical trial NCT06221852?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06221852 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06221852's enrollment target sits among peer trials
50 64th of 103 higher than 35 of 103 other Schizoaffective Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizoaffective Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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