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Tests treatment safety and results for Bipolar I Disorder
Official title Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
ClinicalTrials.gov ID: NCT05837104
What this study is testing
What is Magnesium vitamin B6?
Magnesium vitamin B6 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for bipolar i disorder.
Also referred to as MagnéVie B6®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- Young Mania Rating Scale (YMRS) scores of less than 15
- Ability to sign informed consent.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Belmont, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belmont, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.