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Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

Primary Purpose

Bipolar Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-ketogenic Diet
Ketogenic Diet
No diet
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bipolar Disorder focused on measuring Ketogenic Diet, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: All participants: *18-30 years of age BD hypomanic group (n=30): Meeting sex proportion: 50% female Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5) Young Mania Rating Scale score(YMRS)>10 Score <8 Hamilton Rating Scale for Depression(HRSD) BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD) BD euthymic group (n=30): Meeting sex proportion: 50% female Meeting diagnosis proportion: 50:50% BDI:II (DSM-5) Score <8 on YMRS Score <8 on Hamilton Depression Rating Scale (HRSD) BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD) Healthy Control (HC) Group (n=30): Sex matched with BD groups No psychiatric history Exclusion Criteria: All participants: Not between 18-30 years of age History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report) Mini-Mental State Examination score (cognitive state) <24 Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate<85 Visual disturbance: <20/40 Snellen visual acuity Left/mixed handedness (Annett criteria) History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy Unable to understand English Conditions related to the pancreas, liver, thyroid or gallbladder. Does not have a smartphone with a) iPhone operating system (iOS) version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app BD hypomanic group: Must be meeting sex proportions: not 50% female Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5) Diagnosis of BD in a depressive, manic, or euthymic episode Young Mania Rating Scale score(YMRS)10 or lower Score 8 or higher on Hamilton Rating Scale for Depression(HRSD) Using psychotropic medications other than those allowed in inclusion criteria Head circumference larger than about 58 cm (size restriction of 7Tesla (7T) scanner) BD euthymic group: Not meeting sex proportion: not 50% female Not meeting diagnosis proportion: not 50:50% BDI:II Diagnosis of BD in a depressive, hypomanic, or manic episode Score 8 or higher on YMRS Score 8 or higher on HRSD Using psychotropic medications other than those allowed in inclusion criteria Healthy Control (HC) Group Not sex-matched with BD groups Has psychiatric history

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet

1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet

No diet

Arm Description

Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study

Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study

Participants without Bipolar Disorder will not participate in the diet phases of the study

Outcomes

Primary Outcome Measures

Blood oxygen level-dependent (BOLD) signal at Scan 1
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Blood oxygen level-dependent (BOLD) signal at Scan 2
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Blood oxygen level-dependent (BOLD) signal at Scan 3
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Manic symptoms at Scan 1
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Manic symptoms at Scan 2
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Manic symptoms at Scan 3
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Fasting Glucose at Baseline
Fasting glucose blood levels
Fasting lipids at Baseline
Fasting lipid blood levels
Fasting hepatic function panel at Baseline: total protein
Fasting levels of total protein in the blood
Fasting hepatic function panel at Baseline: albumin
Fasting levels of albumin in the blood
Fasting hepatic function panel at Baseline: bilirubin
Fasting levels of bilirubin in the blood
Fasting hepatic function panel at Baseline: liver enzyme
Fasting levels of liver enzyme in the blood
Fasting Glucose at halfway point through first dietary phase
Fasting glucose blood levels
Fasting lipids at halfway point through first dietary phase
Fasting lipid blood levels
Fasting hepatic function at halfway point through first dietary phase: total protein
Fasting levels of total protein in the blood
Fasting hepatic function at halfway point through first dietary phase: albumin
Fasting levels of albumin in the blood
Fasting hepatic function at halfway point through first dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Fasting hepatic function at halfway point through first dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Fasting Glucose at end of first dietary phase
Fasting glucose blood levels
Fasting lipids at end of first dietary phase
Fasting lipid blood levels
Fasting hepatic function at end of first dietary phase: total protein
Fasting levels of total protein in the blood
Fasting hepatic function at end of first dietary phase: albumin
Fasting levels of albumin in the blood
Fasting hepatic function at end of first dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Fasting hepatic function at end of first dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Fasting Glucose at halfway point through second dietary phase
Fasting glucose blood levels
Fasting lipids at halfway point through second dietary phase
Fasting lipid blood levels
Fasting hepatic function at halfway point through second dietary phase: total protein
Fasting levels of total protein in the blood
Fasting hepatic function at halfway point through second dietary phase: albumin
Fasting levels of albumin in the blood
Fasting hepatic function at halfway point through second dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Fasting hepatic function at halfway point through second dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Fasting Glucose at end of second dietary phase
Fasting glucose blood levels
Fasting lipids at end of second dietary phase
Fasting lipids blood levels
Fasting hepatic function at end of second dietary phase: total protein
Fasting levels of total protein in the blood
Fasting hepatic function at end of second dietary phase: albumin
Fasting levels of albumin in the blood
Fasting hepatic function at end of second dietary phase: bilirubin
Fasting levels of bilirubin in the blood
Fasting hepatic function at end of second dietary phase: liver enzyme
Fasting levels of liver enzyme in the blood
Gamma-aminobutyric acid (GABA) at Baseline
Gamma-aminobutyric acid (GABA) concentrations in the brain
Glutamate at Baseline
Glutamate concentrations in the brain
Lactate at Baseline
Lactate concentrations in the brain
Gamma-aminobutyric acid (GABA) at end of first dietary phase
Gamma-aminobutyric acid (GABA) concentrations in the brain
Glutamate at end of first dietary phase
Glutamate concentrations in the brain
Lactate at end of first dietary phase
Lactate concentrations in the brain
Gamma-aminobutyric acid (GABA) at end of second dietary phase
Gamma-aminobutyric acid (GABA) concentrations in the brain
Glutamate at end of second dietary phase
Glutamate concentrations in the brain
Lactate at end of second dietary phase
Lactate concentrations in the brain

Secondary Outcome Measures

Average total sleep time during Ketogenic vs Normal diet
Total sleep time will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home.
Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet
Rest-activity rhythm interdaily stability will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home
Ecological momentary assessments (EMA) during the first dietary phase: Mood monitoring
Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood
Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring
Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy
Ecological momentary assessments (EMA) during the first dietary phase: Suicidality monitoring
Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans
Ecological momentary assessments (EMA) during the second dietary phase: Mood monitoring
Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood
Ecological momentary assessments (EMA) during the second dietary phase: Energy monitoring
Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy
Ecological momentary assessments (EMA) during the second dietary phase: Suicidality monitoring
Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans

Full Information

First Posted
September 22, 2023
Last Updated
October 5, 2023
Sponsor
University of Pittsburgh
Collaborators
Baszucki Brain Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT06081426
Brief Title
Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)
Official Title
Elucidating Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD): a Multidisciplinary Mechanistic Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Baszucki Brain Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators aim to examine the effect of the ketogenic diet on brain activity, metabolism, and emotions in adults with Bipolar Disorder (BD).
Detailed Description
The investigators hypothesize that a ketogenic diet will enhance levels of the ketone body β-Hydroxybutyrate (beta OHB), resulting in reduced mania/hypomania severity and predisposition to mania/hypomania in individuals with BD. To test this hypothesis in depth, the investigators will use a novel, multidisciplinary mechanistic study using multimodal neuroimaging, peripheral markers of mitochondrial metabolism, and participant-derived induced pluripotent stem cell (iPSC)-derived organoids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Ketogenic Diet, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1st phase Non-ketogenic Diet / 2nd phase Ketogenic Diet
Arm Type
Experimental
Arm Description
Participants with Bipolar Disorder will consume a non-ketogenic diet for the first phase of the study and then a ketogenic diet for the second phase of the study
Arm Title
1st phase Ketogenic Diet / 2nd phase Non-ketogenic Diet
Arm Type
Experimental
Arm Description
Participants with Bipolar Disorder will consume a ketogenic diet for the first phase of the study and then a non-ketogenic diet for the second phase of the study
Arm Title
No diet
Arm Type
Other
Arm Description
Participants without Bipolar Disorder will not participate in the diet phases of the study
Intervention Type
Other
Intervention Name(s)
Non-ketogenic Diet
Intervention Description
Consuming a non-ketogenic diet
Intervention Type
Other
Intervention Name(s)
Ketogenic Diet
Intervention Description
Consuming a ketogenic diet
Intervention Type
Other
Intervention Name(s)
No diet
Intervention Description
Participants without Bipolar Disorder will not participate in the diet phases of the study
Primary Outcome Measure Information:
Title
Blood oxygen level-dependent (BOLD) signal at Scan 1
Description
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Time Frame
Baseline Scan 1 (all participants)
Title
Blood oxygen level-dependent (BOLD) signal at Scan 2
Description
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Blood oxygen level-dependent (BOLD) signal at Scan 3
Description
The blood oxygen level-dependent (BOLD) signal indicates brain activity and connectivity
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Manic symptoms at Scan 1
Description
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Time Frame
Baseline Scan 1 (all participants)
Title
Manic symptoms at Scan 2
Description
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Time Frame
Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Manic symptoms at Scan 3
Description
The Young Mania Rating Scale (YMRS) indicates the level of manic symptoms with a total score that varies between zero (better outcome) and 60 (worse outcome)
Time Frame
Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting Glucose at Baseline
Description
Fasting glucose blood levels
Time Frame
Baseline (all participants)
Title
Fasting lipids at Baseline
Description
Fasting lipid blood levels
Time Frame
Baseline (all participants)
Title
Fasting hepatic function panel at Baseline: total protein
Description
Fasting levels of total protein in the blood
Time Frame
Baseline (all participants)
Title
Fasting hepatic function panel at Baseline: albumin
Description
Fasting levels of albumin in the blood
Time Frame
Baseline (all participants)
Title
Fasting hepatic function panel at Baseline: bilirubin
Description
Fasting levels of bilirubin in the blood
Time Frame
Baseline (all participants)
Title
Fasting hepatic function panel at Baseline: liver enzyme
Description
Fasting levels of liver enzyme in the blood
Time Frame
Baseline (all participants)
Title
Fasting Glucose at halfway point through first dietary phase
Description
Fasting glucose blood levels
Time Frame
Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting lipids at halfway point through first dietary phase
Description
Fasting lipid blood levels
Time Frame
Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through first dietary phase: total protein
Description
Fasting levels of total protein in the blood
Time Frame
Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through first dietary phase: albumin
Description
Fasting levels of albumin in the blood
Time Frame
Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through first dietary phase: bilirubin
Description
Fasting levels of bilirubin in the blood
Time Frame
Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through first dietary phase: liver enzyme
Description
Fasting levels of liver enzyme in the blood
Time Frame
Halfway point through first dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting Glucose at end of first dietary phase
Description
Fasting glucose blood levels
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting lipids at end of first dietary phase
Description
Fasting lipid blood levels
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of first dietary phase: total protein
Description
Fasting levels of total protein in the blood
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of first dietary phase: albumin
Description
Fasting levels of albumin in the blood
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of first dietary phase: bilirubin
Description
Fasting levels of bilirubin in the blood
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of first dietary phase: liver enzyme
Description
Fasting levels of liver enzyme in the blood
Time Frame
End of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting Glucose at halfway point through second dietary phase
Description
Fasting glucose blood levels
Time Frame
Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting lipids at halfway point through second dietary phase
Description
Fasting lipid blood levels
Time Frame
Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through second dietary phase: total protein
Description
Fasting levels of total protein in the blood
Time Frame
Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through second dietary phase: albumin
Description
Fasting levels of albumin in the blood
Time Frame
Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through second dietary phase: bilirubin
Description
Fasting levels of bilirubin in the blood
Time Frame
Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at halfway point through second dietary phase: liver enzyme
Description
Fasting levels of liver enzyme in the blood
Time Frame
Halfway point through second dietary phase (4-5 weeks) (participants with Bipolar Disorder)
Title
Fasting Glucose at end of second dietary phase
Description
Fasting glucose blood levels
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting lipids at end of second dietary phase
Description
Fasting lipids blood levels
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of second dietary phase: total protein
Description
Fasting levels of total protein in the blood
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of second dietary phase: albumin
Description
Fasting levels of albumin in the blood
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of second dietary phase: bilirubin
Description
Fasting levels of bilirubin in the blood
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Fasting hepatic function at end of second dietary phase: liver enzyme
Description
Fasting levels of liver enzyme in the blood
Time Frame
End of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Gamma-aminobutyric acid (GABA) at Baseline
Description
Gamma-aminobutyric acid (GABA) concentrations in the brain
Time Frame
Baseline Scan 1 (all participants)
Title
Glutamate at Baseline
Description
Glutamate concentrations in the brain
Time Frame
Baseline Scan 1 (all participants)
Title
Lactate at Baseline
Description
Lactate concentrations in the brain
Time Frame
Baseline Scan 1 (all participants)
Title
Gamma-aminobutyric acid (GABA) at end of first dietary phase
Description
Gamma-aminobutyric acid (GABA) concentrations in the brain
Time Frame
Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Glutamate at end of first dietary phase
Description
Glutamate concentrations in the brain
Time Frame
Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Lactate at end of first dietary phase
Description
Lactate concentrations in the brain
Time Frame
Scan 2 at end of first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Gamma-aminobutyric acid (GABA) at end of second dietary phase
Description
Gamma-aminobutyric acid (GABA) concentrations in the brain
Time Frame
Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Glutamate at end of second dietary phase
Description
Glutamate concentrations in the brain
Time Frame
Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Lactate at end of second dietary phase
Description
Lactate concentrations in the brain
Time Frame
Scan 3 at end of second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Secondary Outcome Measure Information:
Title
Average total sleep time during Ketogenic vs Normal diet
Description
Total sleep time will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home.
Time Frame
Wrist actigraphy will be collected throughout the 8-10wk ketogenic diet and normal diet study intervals
Title
Average rest-activity rhythm interdaily stability during Ketogenic vs Normal diet
Description
Rest-activity rhythm interdaily stability will be assessed using wrist actigraphy. Wrist actigraphy will be collected continuously, at-home
Time Frame
Wrist actigraphy will be collected throughout the 8-10 wk ketogenic diet and normal diet study intervals.
Title
Ecological momentary assessments (EMA) during the first dietary phase: Mood monitoring
Description
Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood
Time Frame
The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Ecological momentary assessments (EMA) during the first dietary phase: Energy monitoring
Description
Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy
Time Frame
The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Ecological momentary assessments (EMA) during the first dietary phase: Suicidality monitoring
Description
Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans
Time Frame
The first dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Ecological momentary assessments (EMA) during the second dietary phase: Mood monitoring
Description
Mood monitoring in real time in participants with Bipolar Disorder: rate mood on a scale of 1-7 with 1 being very low mood and 7 being very high mood
Time Frame
The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Ecological momentary assessments (EMA) during the second dietary phase: Energy monitoring
Description
Energy monitoring in real time in participants with Bipolar Disorder: rate energy on a scale of 1-7 with 1 being very low energy and 7 being very high energy
Time Frame
The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)
Title
Ecological momentary assessments (EMA) during the second dietary phase: Suicidality monitoring
Description
Suicidality monitoring in real time in participants with Bipolar Disorder: answer yes or no to having self-harm/suicide thoughts and plans
Time Frame
The second dietary phase (8-10 weeks) (participants with Bipolar Disorder)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants: *18-30 years of age BD hypomanic group (n=30): Meeting sex proportion: 50% female Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5) Young Mania Rating Scale score(YMRS)>10 Score <8 Hamilton Rating Scale for Depression(HRSD) BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD) BD euthymic group (n=30): Meeting sex proportion: 50% female Meeting diagnosis proportion: 50:50% BDI:II (DSM-5) Score <8 on YMRS Score <8 on Hamilton Depression Rating Scale (HRSD) BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD) Healthy Control (HC) Group (n=30): Sex matched with BD groups No psychiatric history Exclusion Criteria: All participants: Not between 18-30 years of age History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report) Mini-Mental State Examination score (cognitive state) <24 Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate<85 Visual disturbance: <20/40 Snellen visual acuity Left/mixed handedness (Annett criteria) History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy Unable to understand English Conditions related to the pancreas, liver, thyroid or gallbladder. Does not have a smartphone with a) iPhone operating system (iOS) version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app BD hypomanic group: Must be meeting sex proportions: not 50% female Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5) Diagnosis of BD in a depressive, manic, or euthymic episode Young Mania Rating Scale score(YMRS)10 or lower Score 8 or higher on Hamilton Rating Scale for Depression(HRSD) Using psychotropic medications other than those allowed in inclusion criteria Head circumference larger than about 58 cm (size restriction of 7Tesla (7T) scanner) BD euthymic group: Not meeting sex proportion: not 50% female Not meeting diagnosis proportion: not 50:50% BDI:II Diagnosis of BD in a depressive, hypomanic, or manic episode Score 8 or higher on YMRS Score 8 or higher on HRSD Using psychotropic medications other than those allowed in inclusion criteria Healthy Control (HC) Group Not sex-matched with BD groups Has psychiatric history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Morris-Tillman
Phone
412-383-8206
Email
morristillmanje@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Phillips, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Morris-Tillman
Phone
412-383-8206
Email
morristillmanje@upmc.edu
First Name & Middle Initial & Last Name & Degree
Mary L Phillps, MD, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Informed consent will be collected from study participants that allows for broad sharing of participants' de-identified data. Data transfer procedures will be in accordance with all Institutional Review Board guidelines and federal regulations including HIPAA (Health Insurance Portability and Accountability Act of 1996).
IPD Sharing Time Frame
The principal investigators (PIs) reserve the right to publish on the stated aims in a timely manner. Data will be available for addressing other research questions (i.e. which are not described in funded/pending grants) as soon as the data have been checked for accuracy (a period which will be no later than one year after the completion of each assessment). After the study has ended, the study investigators will continue to test the stated aims, but will also continue to solicit collaborations with outside researchers and to consider data requests in a timely manner.
IPD Sharing Access Criteria
Outside investigators must submit a 1)proposal of the study aims, hypotheses, variables/constructs, analytic approach, and estimated duration of the proposed research; 2)resume, qualifications, source of financial support, and conflict of interest statement; 3)sign a data-sharing agreement and confidentiality statement that stipulates using the data for the stated research purposes only, securing the data using appropriate computer technology, not manipulating the data in order to identify participants, acknowledging the grant that supported data collection and management in publications/presentations, and destroying or returning the data after analyses are complete; 4)obtain approval from their Institutional Review Board, and along with other staff members who have access to the data, submit certificates of the University of Pittsburgh Education and Certification Program in Research Practice Fundamentals or provide written documentation of similar human subjects protection training.

Learn more about this trial

Examining Neurobiological Mechanisms Underlying the Therapeutic Effect of the Ketogenic Diet in Bipolar Disorder (BD)

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