Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
With
Ganeden Biotech, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Able to give Informed Consent
Meet criteria for Irritable Bowel Syndrome
Meet criteria for Major Depressive Disorder
Men and women ages 18 to 65
Women of childbearing potential must be using an adequate methods of contraception
Can be on an antidepressant medications, but must have been on the medication for at least 8 weeks and at a stable dose for 4 weeks
Can be on medications for IBS, but must have been on medications for at least 8 weeks and at a stable dose for 4 weeks
You may not be if
Patients who have failed one or more trials of probiotics for IBS
Patients who report an inadequate response to less than two or more than four adequate trails of antidepressant treatments during the current depressive episode at a therapeutic dose for an adequate duration
Women who are pregnant or breastfeeding
Patients with "alarm signs" or "red flags" as defined by American Gastroenterological Association (AGA) are excluded \[6\], unless they have been fully evaluated to rule out other significant diseases.
Patients with known diagnoses of digestive organic disease, celiac disease and lactose intolerance prior to the screening.
Patients who report an inadequate response (less than 50% decrease in depressive symptom severity) to less than two or more than four prior adequate trials of antidepressant treatments during the current depressive episode (including monotherapy treatment and distinct combination regimens) at a therapeutic dose (as defined by the MGH-ATRQ) and for an adequate duration (minimum six weeks for any monotherapy).
Patients who report treatment with adjunctive medications to their antidepressant for a minimum of four weeks during the current depressive episode.
Patients with a current need for involuntary commitment or who have been hospitalized within four weeks of the Screening Visit for the current major depressive episode.
Patients who have received ECT during the current episode.
Patients who have a current Axis I diagnosis of:
Delirium, dementia, amnestic, or other cognitive disorder; Schizophrenia or other psychotic disorder, based on the PDSQ; Bipolar I or II disorder, based on the PDSQ; Patients with a clinically significant Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Patients experiencing hallucinations, delusions, or any psychotic symptomatology in the current depressive episode.
Patients who have met DSM-IV-TR criteria for any significant substance use disorder within the past six months, based on the PDSQ.
Patients receiving new onset depression-focused psychotherapy within 6 weeks of screening, or at any time during participation in the trial.
Patients who have been previously randomized in a probiotics clinical trial (lifetime).
Patients who have participated in any clinical trial with an investigational drug or device within the past month.
Patients who, in the opinion of the investigator, are actively suicidal or homicidal and at significant risk for suicide or homicide.
Clareo Health | Study of Probiotic GanedenBC30 for Irritable Bowel Syndrome and Major Depressive Disorder
