Treatment of Bipolar Depression With Pentoxifylline

NCT04417049 | Completed Early Phase 1

• 1 other identifier: 20-5219
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 with bipolar depression over an 8-week trial.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (2)

• The recruitment rate

  The feasibility of pentoxifylline as a treatment in bipolar disorder will be measured by recruitment rate

  8 weeks

• The retention rate

  The feasibility of pentoxifylline as a treatment in bipolar disorder will be measured by retention rate of the study.

  8 weeks

Secondary Outcomes (9)

• Safety will be assessed using patient-reported treatment emergent adverse events.

  8 weeks

• Change in depression severity using the Montgomery Asberg Depression Rating Scale (MADRS)

  8 weeks

• Change in cerebral blood flow using ASL MRI imaging

  8 weeks

• Change in inflammatory markers using blood serum and plasma

  8 weeks

• Change in subjective measures of depression using 16-item Quick Inventory for Depressive Symptomology-Self Report (QIDS-SR16) Total Score

  8 weeks

Study Arms (1)

Pentoxifylline

EXPERIMENTAL

Drug: Pentoxifylline 400 MG

Interventions

Pentoxifylline 400 MG DRUG

All patients will be provided with pentoxifylline 400 mg to be orally ingested twice daily for 8 weeks.

Also known as: Trental

Pentoxifylline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joshua D Rosenblat, MD, MSc

  Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: July 12, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 29, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)