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Bipolar I DisorderPhase 2NCT05837104

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

A Phase 2 study testing Magnesium vitamin B6 in people with Bipolar I Disorder and Depression, Anxiety, run by Mclean Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Bipolar I Disorder, Depression, Anxiety, Stress
What is being tested?
Magnesium vitamin B6
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
13 Dec 2023to Oct 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kyle Cuklanz, B.S. contact

617-855-2637

kcuklanz@mclean.harvard.edu

Virginie-Anne Chouinard, M.D. contact

617-855-3034

vchouinard@mclean.harvard.edu

United States1 site, 1 recruiting

  • McLean Hospital

    Belmont, Massachusetts, 02478

    Kyle Cuklanz, B.S., 617-855-2637, kcuklanz@mclean.harvard.edu

    Virginie-Anne Chouinard, M.D., 617-855-3034, vchouinard@mclean.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

After a first episode of bipolar disorder, subsequent depressive and anxiety symptoms can pose a major challenge to an individual's recovery early in the illness. Individuals often have depressive and anxiety symptoms for a significant proportion of their time. These mood and anxiety symptoms are associated with higher risk for relapse, chronicity and disability. Previous studies have shown that the combination of Magnesium-vitamin B6 has beneficial effects on stress, and depressive and anxiety symptoms. This randomized, double-blind, placebo-controlled trial will assess the benefits of Magnesium-vitamin B6 in combination with treatment as usual (standard of clinical care) on depressive and anxiety symptoms and stress in individuals with bipolar disorder in the early phase of illness. 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). Magnesium is a promising targeted intervention for bipolar disorder given its significant effects on energy metabolism.

Being tested
Magnesium vitamin B6, Placebo
Keywords
First episode Bipolar Disorder, Magnesium vitamin B6, Brain energy metabolism, Depression, Anxiety, Stress
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium vitamin B6Drug

    Also called MagnéVie B6®

    Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.

  • PlaceboDrug

    Placebo tablet, three times daily for four weeks.

Study groups in NCT05837104
Study groupRoleWhat they receive
Magnesium vitamin B6ExperimentalMagnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
Receives: Drug: Magnesium vitamin B6
PlaceboPlacebo comparatorPlacebo tablet will be taken three times daily for four weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in depressive symptoms

    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.

    Measured: 4 weeks

Secondary outcomes (10)

  1. Change in anxiety symptoms

    Change from baseline to week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score. Scores range from 0-56; a higher score indicates a higher level of anxiety.

    Measured: 4 weeks

  2. Change in stress symptoms

    Change from baseline to week 4 in Depression Anxiety Stress Scales (DASS-42) Stress Subscale score. Scores range from 0-42; a higher score indicates a higher level of stress.

    Measured: 4 weeks

  3. Change in Clinical Global Impression (CGI) Scale

    Change from baseline to week 4 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.

    Measured: 4 weeks

  4. Change in cognitive measure

    Change from baseline to week 4 in MATRICS Consensus Cognitive Battery (MCCB) Total score. Scores range from 0.00%-100.00%; a higher score indicates higher cognition.

    Measured: 4 weeks

  5. Changes in brain ATP

    Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy.

    Measured: 4 weeks

  6. Changes in brain PCr

    Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy.

    Measured: 4 weeks

  7. Changes in brain pH

    Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy.

    Measured: 4 weeks

  8. Changes in brain inorganic phosphate concentration

    Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy.

    Measured: 4 weeks

  9. Change in brain Mg2+ concentration

    Change from baseline to week 4 in Mg2+ concentration as measured by 31P MRS.

    Measured: 4 weeks

  10. Change in adverse events

    Change from baseline to week 4 in adverse events.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start13 Dec 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05837104
Sponsor's protocol ID
2022P001911
Status last verified
Jun 2026
First submitted
19 Apr 2023
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magnesium vitamin B6 in people with Bipolar I Disorder and Depression, Anxiety, run by Mclean Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kyle Cuklanz, B.S. (617-855-2637, kcuklanz@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depressive symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05837104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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