Can a simple supplement ease bipolar depression? new trial tests magnesium B6
NCT ID NCT05837104
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding magnesium vitamin B6 to usual treatment can reduce depression, anxiety, and stress in people experiencing their first episode of bipolar I disorder. Forty adults aged 18-50 will take either the supplement or a placebo three times daily for four weeks. The goal is to see if this safe, over-the-counter combination can improve mood symptoms early in the illness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- magnesium vitamin B6
- What this could lead to
- If it works, this could point toward a simple, safe supplement to help manage mood symptoms early in bipolar I disorder.
- What could go wrong
- This is a small, early-phase trial with only 40 people over 4 weeks. The supplement may not outperform placebo, and results may not apply to everyone with bipolar disorder.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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McLean Hospital
RECRUITINGBelmont, Massachusetts, 02478, United States
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