What side effects are associated with this type of intervention?

Common treatments for Bipolar Disorder, such as lithium, valproate, and second-generation antipsychotics, have various side effects. Lithium can cause weight gain, tremors, increased thirst, and potential kidney and thyroid issues. Valproate may lead to gastrointestinal disturbances, weight gain, hair loss, and liver toxicity. Second-generation antipsychotics often result in weight gain, metabolic syndrome, and extrapyramidal symptoms like tremors and rigidity. These side effects should be carefully monitored by healthcare providers to ensure optimal treatment outcomes.

What prior FDA approvals exist?

FDA-approved treatments for Bipolar Disorder include mood stabilizers like lithium, anticonvulsants such as valproate and lamotrigine, and atypical antipsychotics like quetiapine and olanzapine. These treatments primarily target neurotransmitter regulation and mood stabilization. While Magnesium and Vitamin B6 are not FDA-approved for Bipolar Disorder, their roles in neurotransmitter function and synthesis suggest potential benefits, similar to the mechanisms of existing treatments.

What other types of research exist?

Promising alternatives to Magnesium-vitamin B6 for Bipolar Disorder patients include: 1) Zinc supplementation, which has shown to enhance the efficacy of conventional antidepressants and has antidepressant activity in various stress models. 2) Omega-3 fatty acids, which have been studied for their role in mood stabilization and have shown some efficacy in mood disorders. 3) Electroconvulsive therapy (ECT), which has demonstrated efficacy in treatment-resistant depression and may be considered for severe cases. 4) B-complex vitamins, particularly B1, B2, and B12, which have shown potential in augmenting antidepressant treatment and improving cognitive function in geriatric depression. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

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Mineral and Vitamin Supplement

Magnesium + Vitamin B6 for Bipolar Disorder

Phase 2

Recruiting

Led By Virginie-Anne Chouinard, M.D.

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Persons between the ages of 18 and 45

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; with HAM-D total scores of 15 or lower.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial tests a mix of magnesium and vitamin B6 supplements for patients who have recently experienced their first episode of bipolar I disorder. The treatment aims to improve mood and reduce anxiety by supporting brain energy production and function.

Who is the study for?

This trial is for adults aged 18-45 with a recent diagnosis of bipolar I disorder, experiencing certain symptoms like depressed mood and anxiety. They should have moderate to severe stress but not be in a manic state, as shown by specific rating scales. Participants must be stable on their current psychiatric meds with no changes expected during the study.

What is being tested?

The trial is testing if adding Magnesium vitamin B6 to usual treatment helps reduce depression, stress, and anxiety in those having their first episode of bipolar I disorder. It's a randomized test where patients won't know if they're getting the actual supplement or a placebo.

What are the potential side effects?

While not specified here, common side effects from supplements like Magnesium vitamin B6 could include stomach upset, diarrhea, or nausea. Since it's being tested for safety too, part of this trial will monitor participants for any unexpected reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 45 years old.

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I have at least two symptoms of depression but my overall depression is mild.

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I am experiencing high levels of stress.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in depressive symptoms

Secondary study objectives

Change in Clinical Global Impression (CGI) Scale

Change in adverse events

Change in anxiety symptoms

+7 more

Other study objectives

Change in Extrapyramidal Symptom Rating Scale (ESRS) total score

Change in Global Functioning Scale - Social and Role (GFS) total score

Change in Mg blood level

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Magnesium vitamin B6Experimental Treatment1 Intervention

Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.

Group II: PlaceboPlacebo Group1 Intervention

Placebo tablet will be taken three times daily for four weeks.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bipolar Disorder, such as lithium, work through neuroprotective and neurotrophic mechanisms, enhancing neuronal plasticity and stabilizing mood by modulating neurotransmitter systems and second messenger pathways. Magnesium supports neurotransmitter function, while Vitamin B6 aids in neurotransmitter synthesis, both crucial for maintaining balanced brain chemistry. These mechanisms are vital for Bipolar Disorder patients as they help stabilize mood swings, reduce the frequency and severity of episodes, and improve overall brain health, thereby enhancing the quality of life.

An Oldie but Goodie: Lithium in the Treatment of Bipolar Disorder through Neuroprotective and Neurotrophic Mechanisms.