Principal Investigator: Perry Renshaw
Keywords: Bipolar Disorder , Veterans , Hypoxia , Altitude Department: Adult Psychiatry
IRB Number: 00100784 Co Investigator: Douglas Kondo
Specialty: Psychiatry
Sub Specialties: Mood Disorders
Recruitment Status: Recruiting

Contact Information

Colleen Fitzgerald

Simple Summary

The goal is to delineate specific bioenergetic treatment targets for bipolar disorder in the brain, through pursuit of the following Specific Aims:Aim 1: To measure changes in phosphocreatine and ATP, that occur in response to acute hypoxic stress in bipolar disorder and healthy controls;Aim 2: To quantity peripheral HIF-1 levels in bipolar disorder and healthy control Veterans residing at moderate altitude;Aim 3: To explore the association between the and peripheral HIF-1 levels in bipolar disorder and healthy control Veterans.

Inclusion Criteria

General Inclusion Criteria for All Study Subjects:

1) Age 18 to 65 years;

2) Absence of unstable medical or neurological conditions as determined by medical history, physical examination, 12-lead electrocardiogram (ECG) and laboratory tests including a complete blood count and metabolic panel;

3) Capable of providing valid informed consent, which includes compliance with the study requirements listed in the consent form.

General Inclusion Criteria for Bipolar Disorder Subjects:

1) Diagnosis of Bipolar I Disorder, confirmed by clinical interview and standardized diagnostic interview;

2) A euthymic or depressive mood state at time of screening, based on the judgment of the study physician, and a Young Mania Rating Scale (YMRS) score < 7.

Specific Altitude-Related Inclusion Criteria for All Study Subjects:

1) Resident of the Inter-Mountain West for a minimum of 2 months;

2) No out-of-region travel for 2 months prior to study entry;

3) No air travel within 2 months of study enrollment, or during study participation.

Exclusion Criteria

General Exclusion Criteria for All Study Subjects:

1) Alcohol or substance use disorder within 3 months of enrollment in the study, confirmed by clinical interview and standardized diagnostic interview, and/or positive urine drug screen;

2) Weight of 375 pounds or greater;

3) History of known or suspected intellectual disability or sub-average intelligence;

4) Contraindication to MRI scanning, e.g. ferrometallic implant;

5) History of clinically-significant claustrophobic anxiety;

6) Presence of a clinically unstable hypoxic pulmonary disease (such as chronic obstructive pulmonary disease), as determined by study physician. 

7) Concurrent participation in another clinical study in which the Veteran is, will be, or has been exposed to an investigational or a non-investigational drug or device within 4 weeks prior to brain scanning;

8) Pregnant women and breastfeeding mothers will be excluded.

Exclusion Criteria for All Bipolar Disorder Subjects:

1) Substance use disorder within the previous 3 months;

2) Any of the following BD specifiers at the time of screening: a manic episode, rapid cycling, seasonal pattern, or without inter-episode recovery.

Exclusion Criteria for Healthy Comparison Subjects:

1) Current psychiatric or substance use disorder;

2) Current treatment with psychotropic medication.

Participant Reimbursement

1. Screening - regardless of eligibility, participants will receive $75.002. Scan Visit - participants will be compensated $100.00 upon completion of the scan visit.