NCT05837104 · Mclean Hospital
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment proof-of-concept clinical trial to assess the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
Magnesium vitamin B6
Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
DRUG
Placebo
Placebo tablet, three times daily for four weeks.
Primary outcome measures
Change in depressive symptoms
Time frame: 4 weeks
Change from baseline to week 4 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Belmont, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations