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Theophylline for Depression Study (T-DEP)

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status and phase

Withdrawn
Early Phase 1

Conditions

Depression

Treatments

Other: PO placebo
Biological: Lipopolysaccharide (LPS)
Drug: Theophylline ER
Other: IV placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT04309877
20-000005

Details and patient eligibility

About

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 result of aging, obesity, chronic diseases, or certain treatments (e.g., interferon for hepatitis C) appear to cause depressive symptoms and even clinical depression. Individuals with such inflammations are more likely to suffer from depression and are less likely to respond to currently available antidepressant medications. This study will test theophylline, a medication currently used for asthma treatment, as a new way to mitigate depressive symptoms in response to such inflammations. This study begins with a 90-minute screening session to determine whether participants are eligible to join the main study. Those who meet the eligibility criteria will then join the main study, which will consist of taking theophylline or methylcellulose (i.e., oral placebo) for 2 weeks at home and an 8-hour session at the UCLA Medical Center. Approximately 20 healthy adults will be recruited for participation in the study. During the course of the study, participants will take theophylline or methylcellulose for 2 weeks at home and then will be injected either lipopolysaccharide (LPS) or saline (i.e., intravenous placebo) at the UCLA Medical Center. LPS is a bacterial substance that can initiate chemical reactions that are similar to those seen in individuals with mild sickness symptoms, such as a slight increase in body temperature, muscle aches, or tiredness. It is a safe way of investigating the body's response to inflammation and how these changes may alter cognitive, emotional, or neural function. It has been given thousands of times to healthy volunteers - both younger and older adults - without any serious side effects.

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

0 participants in 4 patient groups, including a placebo group

PO theophylline & IV LPS
Experimental group
Description:
Oral (PO) theophylline 400 mg/day for 2 weeks followed by a single intravenous (IV) bolus of lipopolysaccharide (LPS) 0.8 ng/kg of body weight
Treatment:
Biological: Lipopolysaccharide (LPS)
Drug: Theophylline ER
PO placebo & IV LPS
Experimental group
Description:
PO methylcellulose (placebo) daily for 2 weeks followed by a single intravenous (IV) bolus of lipopolysaccharide (LPS) 0.8 ng/kg of body weight
Treatment:
Biological: Lipopolysaccharide (LPS)
Other: PO placebo
PO theophylline & IV placebo
Experimental group
Description:
PO theophylline 400 mg/day for 2 weeks followed by a single IV bolus of 0.9% saline
Treatment:
Other: IV placebo
Drug: Theophylline ER
PO placebo & IV placebo
Placebo Comparator group
Description:
PO methylcellulose (placebo) daily for 2 weeks followed by a single IV bolus of 0.9% saline
Treatment:
Other: IV placebo
Other: PO placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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