The Safety and Effectiveness of Probiotic Supplementation on Bipolar Depression (ALIGN)

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar, Depression, Probiotic, ALIGN, HAMD, STAI, YMRS, CGI, SDS, WHOQOL-BREF, C-SSRS, TSES Read More

Inclusion Criteria:

• Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English
• Male and Female participants 18 - 65 years of age ,inclusive, at the time of screening
• Demonstrates a diagnosis of bipolar depression (type I or II) according to the Mini International Neuropsychiatric interview (MINI)
• Is not hospitalized or institutionalized (outpatient) at the time of screening
• Have been on a stable (unchanged) and adequate dose of one of the permissible medications for at least 8 weeks prior to screening (lithium, valproate/divalproex, carbamazepine, lamotrigine, quetiapine/quetiapine XR, olanzapine, or risperidone)
• Demonstrates a maximum HAM-D score of 24 at screening and baseline visits
• Female participants Must:

Not be breast feeding Not be pregnant or seeking to get pregnant during the course of this study. Be menopausal or using an acceptable method of birth control (implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or a vasectomized partner)

Exclusion Criteria:

• Demonstrates or reports a history of any of the DSM-IV criteria for classification of substance abuse/dependence disorders in the past year.
• Demonstrates the presence of active eating disorders, schizophrenia or schizoaffective disorder
• Demonstrates current psychotic symptoms
• Demonstrates a Young Mania Rating Scale (YMRS) score of >12 at screening
• Demonstrates active suicidality based on the C-SSR scale
• Reports using any potent cytochrome P450 inhibitors (such as chloramphenicol, antifungal agents) during the 14 days prior to screening
• Reports a history of electroconvulsive therapy (ECT) during the 90 days prior to screening
• Reports using Align or any other probiotic supplement within the last year prior to screening
• Reports a history of allergic response(s) to components of Align (such as Bifidobacterioum), or any other related drug.
• Reports a presence or history of any medical conditions that would affect drug pharmacokinetics (gastrointestinal conditions such as chroris or colitus).
• Reports a history of any immunocompromising condition (such as HIV, lymphoma, patients undergoing long-term corticosteroid treatment)
• Currently experiencing nausea, fever, vomiting, bloody diarrhea or severe abdominal pain
• Reports use of other natural health products (in addition to probiotics) that affect depression (such as St. Johns Wart, Tryptophan) within the last 6 months prior to screening
• Reports frequent consumption of foods rich in / enriched with probiotics (e.g. yoghurt, drinks, e.t.c).