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

Primary Purpose

Bipolar I Disorder, Depression, Anxiety, Stress

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Magnesium vitamin B6
Placebo
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar I Disorder focused on measuring First episode Bipolar Disorder, Magnesium vitamin B6, Brain energy metabolism, Depression, Anxiety, Stress

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Persons between the ages of 18 and 45 DSM V diagnosis of bipolar I disorder, onset of illness in the last 7 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; with HAM-D total scores of 15 or lower. Moderate to extremely severe stress at screening, defined as a DASS-42 stress subscale score of >18 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 currently taking antidepressants. 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Magnesium vitamin B6

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Changes in brain energy metabolism markers
    Change from baseline to week 4 in brain energy metabolites and pH as measured by 31P magnetic resonance spectroscopy.
    Change in brain Mg2+ concentration
    Change from baseline to week 4 in Mg2+ concentration as measured by 31P MRS.
    Change in adverse events
    Change from baseline to week 4 in adverse events.

    Full Information

    First Posted
    April 19, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Mclean Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05837104
    Brief Title
    Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mclean Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar I Disorder, Depression, Anxiety, Stress
    Keywords
    First episode Bipolar Disorder, Magnesium vitamin B6, Brain energy metabolism, Depression, Anxiety, Stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Magnesium vitamin B6
    Arm Type
    Experimental
    Arm Description
    Magnesium vitamin B6 (MagnéVie B6®) composed of Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablet will be taken three times daily for four weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium vitamin B6
    Other Intervention Name(s)
    MagnéVie B6®
    Intervention Description
    Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablet, three times daily for four weeks.
    Primary Outcome Measure Information:
    Title
    Change in depressive symptoms
    Description
    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.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Change in anxiety symptoms
    Description
    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.
    Time Frame
    4 weeks
    Title
    Change in stress symptoms
    Description
    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.
    Time Frame
    4 weeks
    Title
    Change in Clinical Global Impression (CGI) Scale
    Description
    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.
    Time Frame
    4 weeks
    Title
    Change in cognitive measure
    Description
    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.
    Time Frame
    4 weeks
    Title
    Changes in brain energy metabolism markers
    Description
    Change from baseline to week 4 in brain energy metabolites and pH as measured by 31P magnetic resonance spectroscopy.
    Time Frame
    4 weeks
    Title
    Change in brain Mg2+ concentration
    Description
    Change from baseline to week 4 in Mg2+ concentration as measured by 31P MRS.
    Time Frame
    4 weeks
    Title
    Change in adverse events
    Description
    Change from baseline to week 4 in adverse events.
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change in World Health Organization Disability Assessment Schedule (WHODAS) score
    Description
    Change from baseline to week 4 in World Health Organization Disability Assessment Schedule (WHODAS) scale. Scores range from 0-144; a higher score indicates greater dysfunction and disability in major life domains.
    Time Frame
    4 weeks
    Title
    Change in World Health Organization Quality of Life (WHOQOL) score
    Description
    Change from baseline to week 4 in World Health Organization Quality of Life (WHOQOL) scale. Scores range from 1-130; a lower score indicates lower perceived quality of life.
    Time Frame
    4 weeks
    Title
    Change in Mg blood level
    Description
    Change from baseline to week 4 in Mg blood levels.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Persons between the ages of 18 and 45 DSM V diagnosis of bipolar I disorder, onset of illness in the last 7 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; with HAM-D total scores of 15 or lower. Moderate to extremely severe stress at screening, defined as a DASS-42 stress subscale score of >18 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 currently taking antidepressants. 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Virginie-Anne Chouinard, M.D.
    Phone
    617-855-3034
    Email
    vchouinard@mclean.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dost Ongur, MD, PhD
    Phone
    617-855-2486
    Email
    dongur@partners.org

    12. IPD Sharing Statement

    Learn more about this trial

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

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