Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University Health Network, Toronto
With
Clinical Investigation Centre for Innovative Technology Network
Stanford University
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Fifth edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) criteria for major depressive episode as part of bipolar I/II disorder and are able to provide written informed consent
HAMD-17 score \>= 20
Young Mania Rating Scale score \< 12
Previous failed trial (i.e., inefficacy) of quetiapine and one other Canadian Network for Mood and Anxiety Treatments (CANMAT) BD guideline/FDA approved first line treatment for the depressive phase of BD during the index episode and/or during a prior episode
Currently prescribed conventional mood stabilizer or atypical antipsychotic agent
Received conventional treatment for bipolar depression for a minimum of 4 weeks prior to randomization
Females of childbearing potential must test negative for pregnancy and must be using adequate birth control measures throughout the study and must continue such precautions for 6 months after receiving the last study drug administration.
Participants will also need to meet one of the following inflammatory indicators:
1. Central Obesity (ethnicity-specific waist circumference - see table below for specific values) OR BMI ≥30 kg/m2.
AND
* Raised triglycerides: ≥1.7 mmol/L (150 mg/dL) or specific treatment for this lipid abnormality OR
* Reduced HDL-cholesterol: \<1.03 mmol/L (40 mg/dL) in males; \<1.29 mmol/L (50 mg/dL) in females or specific treatment for this lipid abnormality OR
* Raised Blood Pressure: Raised blood pressure Systolic: ≥130 mm Hg or diastolic: ≥85 mm Hg or treatment of previously diagnosed hypertension.
2. Diabetes: 8-hour fasting plasma glucose ≥ 7.0 mmol/L or Hb-A1C test ≥ 6.5% (as per the 2013 CDA diagnostic criteria) or previously diagnosed type 1 or 2 diabetes (current prescription medication for diabetes acceptable of diagnosis). Participants with child onset of diabetes will be excluded.
5. Smoking cigarettes (daily - minimum of ½ pack).
6. High sensitivity C-reactive protein level of ≥5 mg/L via blood test at screening
You may not be if
Another concurrent psychiatric disorder that requires primary clinical attention
History of schizophrenia
Active psychotic symptoms
Substance abuse and/or dependence within past 6 months
Electroconvulsive therapy in the past 6 months
Actively suicidal or evaluated as being a suicide risk \[HAMD-17 suicide item \>= 3 or Montogomery Asberg Depression Rating Scale (MADRS) suicide item \>= 4, or according to clinical judgement using the C-SSRS\]
Clinically significant unstable medical illness
Severe infections such as sepsis, abscess, tuberculosis and opportunistic infections
Viral hepatitis B
History of Hepatitis C ( documented or suspected)
Any autoimmune disorder
History of tuberculosis or a high risk of tuberculosis exposure
Human Immunodeficiency Virus confirmed by laboratory testing
Active fungal infection
History of recurrent viral or bacterial infections
Received within 3 months prior to screening or are expected to receive any live viral vaccine or live bacterial vaccinations during the trial or up to 3 months after the last administration of study agent
C. difficile infection within the past 4 months
History of lymphoproliferative disease
History of cancer, excluding basal cell or squamous cell carcinoma of the skin (fully excised with no recurrence)
Unstable cardiovascular, endocrinological, hematological, hepatic, renal or neurological disease determined by physical examination and laboratory testing
Concomitant diagnosis or any history of congestive heart failure
Concomitant treatment with non-steroidal and steroidal anti-inflammatory medications or other biologics
Current or past exposure to anti-TNF biologics
Previous immediate hypersensitivity response, including anaphylaxis to an immunoglobulin product (plasma-derived or recombinant, e.g. monoclonal antibody)
Known allergies, hypersensitivity or intolerance to infliximab or its excipients
Known allergy to murine proteins or other chimeric proteins
Currently on or have used any investigational drug within 30 days prior to screening, or within 5 half-lives of the investigational agent
Females who are pregnant or breastfeeding
Clareo Health | 12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression
