Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT05837104
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05837104
Study Brief:
Protocol Section:
NCT05837104