Phase 2 Bipolar Disorder Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 50 years of age
• People who have been diagnosed with Bipolar I Disorder (using the DSM-5 criteria), where the illness began within the last 10 years
• People who are currently experiencing at least two specific depression-related symptoms, such as depressed mood, feelings of guilt, anxiety, physical symptoms of anxiety, general tiredness or body complaints, or digestive/stomach symptoms, as measured by a standard rating scale
• People whose mania symptoms score below a certain level on a standard rating scale (confirm with trial site)
• People who are able to read and sign a consent form
• People whose condition has been stable, with no changes to their psychiatric medications in the two weeks before screening, and who are not expected to need any new psychiatric medications during the four weeks of the study

Who may not be able to join:

• People who are unable to sign a consent form
• People who weigh more than 350 pounds
• People who choose not to participate
• People diagnosed with Bipolar Not Otherwise Specified, Cyclothymia, or Schizoaffective Disorder (Bipolar type)
• People currently experiencing two or more manic symptoms that meet DSM-5 criteria
• People who are capable of becoming pregnant and are not using a medically accepted form of contraception
• People considered to be at serious risk of suicide or harming others
• People with unstable physical health conditions affecting the heart, liver, kidneys, lungs, hormonal system, nervous system, or blood
• People with certain other mental health diagnoses, including active substance or alcohol use disorder (within the last 2 months), schizophrenia, delusional disorder, unspecified psychotic disorder, schizoaffective disorder, recent bereavement, or severe borderline or antisocial personality disorder
• People who meet the criteria for a bipolar mixed episode
• People who have taken levodopa, quinidine, or proton-pump inhibitors (a type of medication often used for stomach acid) within the three months before screening
• People with very low magnesium levels in their blood (confirm with trial site)
• People who have taken an experimental psychiatric medication within the past six months, unless it was a single one-time dose
• People who have a seizure disorder (epilepsy)
• People currently taking certain dietary supplements, including SAMe, St. John's Wort, DHEA, Inositol, or Ginkgo biloba
• People who have previously undergone vagus nerve stimulation or deep brain stimulation procedures
• People who have had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last three months
• People with a medical condition that would make blood draws unsafe or not possible
• People with a history of a significant head injury
• People with certain rare inherited conditions affecting how the body processes certain sugars, specifically galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome
• People with a known allergy to magnesium citrate anhydrous, pyridoxine hydrochloride, or any other ingredient in a supplement called Magne B6
• People currently taking stimulant medications

Important: Always verify eligibility with the trial site directly before applying.