utritional intervention in bipolar disorder and schizophrenia

Not Applicable

• Conditions: Schizophrenia; Bipolar disorder; Mental Health - Schizophrenia; Mental Health - Other mental health disorders

• Registration Number: ACTRN12623000854639
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-08
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Meet the DSM-4 diagnostic criteria for bipolar disorder or meet the DSM-5 diagnostic criteria for schizophrenia for at least 6 months, assessed using the MINI Neuropsychiatric Interview
2) Clinically stable is defined as 3 months with no relapses.
3) Able to provide informed consent to take part in the study.
4) Able to speak, read and understand English to a level whereby they can understand the participant information sheet (PIS).
5) Able to understand basic principles of the specific diet
6) Ability to complete an accurate diet and symptom diary as well as questionnaires required.

Exclusion Criteria

1) Pregnancy or breastfeeding (or those planning to become pregnant within 3 months)
2) Active substance misuse with alcohol or illicit drugs
3) Use of the ketogenic diet in the previous 2 months
4) Currently following a vegan diet
5) Admission to a hospital within the past 3 months
6) Current involvement in another research study (This feasibility study is of moderate intensity and requires daily monitoring and a significant dietary intervention requiring careful planning. As such it would not be appropriate for participants involved in other current research to take part due to the potentially high level of burden on them. Those involved in recent research that has ended by the time of recruitment to this study would be eligible, and will be made fully aware of the level of engagement required to allow them to make an informed decision)
7) Inability to complete week 0 assessments
8) Clinically significant liver or kidney disease
9) Clinically significant cardiovascular disease
10) Severe hyperlipidemia
11) Type 1 diabetes
12) History of eating disorder
13) BMI < 18.5kg
14) On medication that can cause ketosis
15) Not willing to change diet or unable to change diet due to medical reasons
16) No access to cooking facilities and ingredients to prepare recipes following the specific diet.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change on the Young Mania Rating Scale” (YMRS)[The outcome will be measured using the appropriate scales by a trained psychiatrist at the assessments in week 0 (baseline), week 8 and week 14 (end of trial).];Change on the Positive and Negative Syndrome Scale” (PANSS)[Changes will be assessed at baseline (week 0), week 8 and week 14 (end of trial). ];Change on the Affect Liability Scale” (ALS-18)[Changes will be assessed at baseline (week 0), week 8 and week 14 (end of trial). ]