Status:
RECRUITING
The Effects of Fluoxetine and/or DHEA
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
(1) To determine how the Selective Serotonin Reuptake Inhibitor (SSRI), fluoxetine (Prozac), an antidepressant often used to treat depression, stimulates the participant's body's ability to defend aga...
Eligibility Criteria
Inclusion
- 64 (32 males, 32 females) T1DM patients aged 18-50 yr.
- HbA1c \< 11.0%
- No clinically diagnosed diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc)
- Body mass index \< 40kg · m-2
Exclusion
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens
- Subjects with a recent medical illness or past history of severe depression, mania or psychotic disease
- Subjects that score greater than 50 on the depression scale
- Subjects unwillingness or inability to comply with approved contraception measures
- Abnormal results following screening tests and physical examination that are clinically significant
- Subjects with a history of severe uncontrolled hypertension (i.e., blood pressure greater than 160/100), heart disease, cerebrovascular incidents
- Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects ≥ 40 years old.
- Pneumonia
- Hepatic Failure/Jaundice
- Creatinine greater than 1.6 mg/dl
- Acute Cerebrovascular/ Neurological deficit
- Fever greater than 38 °C
- Screening Laboratory Tests Exclusion Criteria
- Hematocrit lower than 32
- WBC lower than 3 thou/ul or greater than 14 thou/ul
- Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L).
- TBil greater than 2 mg/dl
- Alkaline Phosphatase greater than 150U/L
- Positive HIV, Hep B, Hep C
- Hepatic transaminase \> 2x normal
Key Trial Info
Start Date :
December 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03228732
Start Date
December 19 2017
End Date
December 15 2026
Last Update
October 6 2025
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21201