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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. - 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 Should NOT Join This Trial: - Unable to sign willing to sign a consent form. - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

McLean Hospital
Belmont, Massachusetts, United States