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RecruitingPhase 2

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy and Safety of Magnesium Vitamin B6 in Combination With Treatment as Usual in First Episode of Bipolar I Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In addition, the investigators aim to assess the effects of Magnesium-vitamin B6 on brain free \[Mg2+\] and energy metabolism, observed to be altered in bipolar disorder, measured by in vivo 31P magnetic resonance spectroscopy (31P MRS)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether magnesium and vitamin B6, added to usual care, safely help with depression, stress, and anxiety. It is for adults ages 18 to 50 with a first episode of bipolar I disorder, which can cause extreme changes in mood and energy. The study compares the supplement with a placebo, a pill with no active treatment.

This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 50 years old.
  • You have bipolar I disorder diagnosed using standard guidelines, and your illness began within the last 10 years.
  • You have at least 2 listed symptoms on a depression rating scale: low mood, guilt, anxious thoughts, physical signs of anxiety, general body symptoms, or stomach and bowel symptoms.
  • Your score is below 15 on the Young Mania Rating Scale, which measures unusually high mood, energy, or activity.
  • You can sign a form agreeing to join the study after learning about it.
  • Your condition is stable. Your mental health medicines have not changed in the 2 weeks before screening, and you are not expected to need new ones during the 4-week study.

Who can't join

  • You cannot sign the consent form, do not want to join, weigh over 350 pounds, or could become pregnant but are not using medically accepted birth control.
  • You have another listed mood disorder: bipolar disorder not otherwise specified, cyclothymia (repeated mood swings), or schizoaffective disorder. You have 2 or more manic symptoms that meet standard guidelines, or a mixed episode with both manic and depression symptoms.
  • You have a serious risk of harming yourself or others; a substance use disorder, including alcohol, active within the past 2 months; schizophrenia; delusional disorder; another listed disorder involving loss of touch with reality; recent intense grief; or severe borderline or antisocial personality disorder.
  • You have an unstable medical illness, including heart, liver, kidney, lung, hormone, nerve, or blood disease; a seizure disorder; a major past head injury; or a condition that prevents blood draws.
  • You used levodopa, quinidine, or proton-pump inhibitors (stomach acid medicines) within 3 months before screening. You took an experimental mental health drug within 6 months, unless it was only one dose. You take stimulant medicine or supplements including SAMe, St. John’s wort, DHEA, inositol, or ginkgo biloba.
  • You have had vagus nerve stimulation or deep brain stimulation, treatments that use electrical signals. You had electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS), treatments that stimulate the brain, within the past 3 months.
  • You have severely low magnesium in your blood: a level of 0.45 mmol/L.
  • You have a listed inherited problem digesting certain sugars: galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. You are allergic to magnesium citrate anhydrous, pyridoxine hydrochloride (vitamin B6), or any other ingredient in Magne B6.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Persons between the ages of 18 and 50 * DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years * Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal. * Young Mania Rating Scale (YMRS) scores of less than 15 * Ability to sign informed consent. * Stable disorder and no change in psychiatric medications within 2 weeks of screening and expected to not require addition of any new psychiatric medications during the duration of the 4 weeks of the study. Exclusion Criteria: * Unable to sign informed consent. * Persons weighing over 350lbs. * Declines to participate. * Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type. * 2 or more manic symptoms that meet DSM-V criteria. * Persons of childbearing potential who are not using a medically accepted means of contraception. * Persons who are deemed a serious suicide or homicide risk. * Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease. * The following DSM-V diagnoses: 1) substance use disorders, including alcohol, active within 2 months; 2) schizophrenia; 3) delusional disorder; 4) psychotic disorders not otherwise specified; 5) schizoaffective disorder; 6) acute bereavement; 7) severe borderline or antisocial personality disorder. * Persons meeting criteria for bipolar mixed episode. * Exposure to levodopa, quinidine, and proton-pump inhibitors within 3 months prior to screening. * Severe hypomagnesemia (serum magnesium of 0.45 mmol/L). * Persons who have taken an investigational psychotropic drug within the past 6 months unless the investigational drug was a one-time dose. * Seizure disorder. * Dietary supplements including SAMe, St. John's Wort, DHEA, Inositol, and Ginko biloba. * Previous treatment with the following procedures: vagus nerve stimulation, or deep brain stimulation. * Have a history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months. * Have any medical condition that would prevent blood draws. * Have a history of significant head injury. * Individuals with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome (rare hereditary diseases) * Individuals with allergies to magnesium citrate anhydrous, pyridoxine hydrochloride or any of the other components of Magne B6 * Patients taking psychostimulant medication

Study sites (1)

MA