Status:
WITHDRAWN
Theophylline for Depression Study
Lead Sponsor:
University of California, Los Angeles
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
Depression is very common and poses a huge disease burden. About 20% of the US population suffers from depression at least once in their lifetime. Inflammations that are hidden inside our body as a re...
Eligibility Criteria
Inclusion
- in good general health (as evaluated during the phone and in-person screening sessions)
- aged 18-65 years
- if female, using adequate birth control
Exclusion
- history of hypersensitivity to xanthine derivatives (a contraindication to theophylline treatment)
- pregnant or planning to become pregnant in the next 6 months
- current breastfeeding
- chronic diseases such as cardiovascular disease, hepatic impairment, peptic ulcer disease, and seizure disorders
- current use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, immune modifying drugs, opioid analgesics, and psychotropics
- Axis I psychiatric disorders including current major depressive disorder
- current depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9 ≥ 5)
- heavy smoking (1 pack or more per day)
- excessive caffeine use (\>600 mg/day)
- Body-mass index \> 35 due to the effects of obesity on cytokine activity
- evidence of recreational drug use from urine test
- evidence of pregnancy from urine test
- evidence of clinically significant rhythm abnormality on a resting electrocardiogram (ECG)
- clinically significant abnormalities on screening laboratory tests
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04309877
Start Date
March 1 2023
End Date
June 1 2025
Last Update
November 5 2021
Active Locations (1)
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1
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, United States, 90095