Status:
COMPLETED
Treatment of Bipolar Depression With Pentoxifylline
Lead Sponsor:
University Health Network, Toronto
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Growing theoretical and clinical evidence has suggested that pentoxifylline may have an effect in improving depressive symptoms. Herein, we aim to evaluate the effect of pentoxifylline in patients wit...
Detailed Description
Growing evidence has demonstrated that inflammation and alterations in cerebral blood flow (CBF) contribute to the pathophysiology of bipolar depression (BD). Pentoxifylline is a phosphodiesterase inh...
Eligibility Criteria
Inclusion
- Provide written, voluntary informed consent prior to study enrollment. Substitute decision makers will not be allowed to consent to study on a potential patients behalf.
- Male or female between the age of 18 to 65, inclusive.
- Meets DSM-5 criteria for Bipolar I or II Disorder, currently experiencing a Major Depressive Episode. Diagnosis will be confirmed using the Mini-International Neuropsychiatric Interview (MINI) conducted by a delegated physician or trained research study while assessing eligibility.
- Patient must present with a moderate to severe depressive episode, as determined by the MADRS score greater than 21.
- Patient must be receiving guideline-concordant pharmacotherapy without changes in the last month.
Exclusion
- Currently exhibiting symptoms of mania, as determined by the Young Mania Rating Scale (YMRS) score greater than 11.
- Current symptoms of psychosis or perceptual disturbances of any kind per investigator discretion
- History of neurological disorders
- Presence of active suicidality, as determined by the MADRS suicidality item (Item #10) score greater than 4
- Presence of a contraindication to PTX, including a drug allergy or allergy to xanthine derivatives, low or labile blood pressure, acute myocardial infarction, cardiac arrhythmia, peptic ulcers, coronary artery disease or coagulation disorder.
- Renal impairment, assessed as creatinine clearance less than 80ml/min
- Abnormal liver function, assessed as ALT or AST ≥ 3 x ULN or bilirubin ≥ 2 x ULN
- Severe myocardial infarction
- Patients with standard contraindications to magnetic resonance imaging (MRI), such as non-MRI compatible implanted metallic devices
- Patients with a history of cerebrovascular disease or history of intercranial hemorrhage.
- Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy
- Pregnant or breastfeeding women. Patients who are sexually active must agree to use a highly effective contraceptive method
- Use of prohibited concomitant medications
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04417049
Start Date
July 12 2021
End Date
November 29 2021
Last Update
April 15 2022
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8