Clinical Trials Logo
  1. Home
  2. Schizoaffective Disorder
  3. NCT06221852

Ketogenic and Nutritional Interventions for First Episode Bipolar Disorder

Schizoaffective Disorder Clinical Trial

Official title:
A Randomized Controlled Clinical Trial of Ketogenic and Nutritional Interventions for Brain Energy Metabolism and Psychiatric Symptoms in First Episode Bipolar Disorder.

Clinical Trial 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.

Clinical Trial Description

Several lines of evidence show energy metabolism and redox dysregulation in bipolar disorder and psychotic disorders. Ketogenic interventions targeting energy metabolism are promising therapeutic approaches to improve mood and psychosis in bipolar disorder and other psychotic disorders. Early intervention is also critical to helping people achieve their goals for recovery after a first episode. Investigators aim to use multimodal imaging and metabolic measures to study the effects of a ketogenic diet intervention on energy metabolism and psychiatric symptoms in individuals with first episode bipolar disorder and schizoaffective disorder. This 12-week randomized controlled trial will assess the benefits of a ketogenic diet in combination with treatment as usual compared to a standard diet. Investigators will measure the effects of nutritional ketosis on brain redox and energy metabolism and other neurometabolic markers using magnetic resonance spectroscopy. Furthermore, investigators will measure the effects of the ketogenic diet on mood and psychotic symptoms and metabolic measures such as insulin resistance. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06221852
Study type Interventional
Source Mclean Hospital
Contact Jacey Anderson, B.A.
Phone 617-855-3988
Email janderson75@mclean.harvard.edu
Status Recruiting
Phase N/A
Start date March 12, 2024
Completion date December 30, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT01878513 - Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Not yet recruiting NCT04551027 - Assessing the Effect of Compensatory Cognitive Intervention Among People With Severe Mental Illness N/A
Terminated NCT02796144 - MEtformin and Lorcaserin for WeighT Loss in Schizophrenia Phase 4
Completed NCT02901587 - Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder Phase 1
Completed NCT02160249 - RISE (Rehabilitation Intervention for People With Schizophrenia in Ethiopia) N/A
Recruiting NCT02986490 - Magnesium Variations and Cardiometabolic Risk in Patients With Antipsychotic Drugs N/A
Completed NCT02417142 - Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia Phase 4
Terminated NCT02234752 - Galantamine and Memantine Combination for Cognitive Impairments in Schizophrenia Phase 2
Completed NCT02091388 - Bioavailability of LY03004 and Risperdal® Consta® Phase 1
Completed NCT01975584 - Neuroendocrine and Immune Response to Stress in Schizophrenia N/A
Completed NCT01945333 - Personalized and Scalable Cognitive Remediation Approaches N/A
Completed NCT01992393 - Targeted Self-Management for Epilepsy and Serious Mental Illness (TIME) N/A
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Completed NCT01658150 - Evaluating Isradipine for Cognitive Enhancement in Schizophrenia and Schizoaffective Disorder N/A
Completed NCT01683539 - Understanding How Cognitive Remediation Works N/A
Completed NCT01193153 - A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder Phase 3