Icariin to Prevent Corticosteroid-related Memory Changes
NCT ID: NCT02112123
Last Updated: 2017-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2014-04-30
2016-12-31
Brief Summary
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Detailed Description
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Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.
24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Placebo
Matching placebo given for 5 days (qd po)
Matching placebo
Icariin - 100 mg/day
Icariin given at 100 mg/day (qd po) for 5 days
Icariin
Icariin - 200 mg/day
Icariin given at 200 mg/day (qd po) for 5 days
Icariin
Icariin - 400 mg/day
Icariin given at 400 mg/day (qd po) for 5 days
Icariin
Icariin - 840 mg/day
Icariin given at 840 mg/day (qd po) for 5 days
Icariin
Icariin - 1680 mg/day
Icariin given at 1680 mg/day (qd po) for 5 days
Icariin
Interventions
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Icariin
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 18 - 50 years
* BMI between 18.5 and 30
* Ability to read and speak English
* Education of 12 or more years or equivalent (at least GED received)
Exclusion Criteria
* History of psychotropic medication therapy in the past 30 days
* Current or past 30 days opioid therapy
* Current or past 30 days erectile dysfunction therapy
* Significant medical conditions
* Hypertensive blood pressure, defined as either systolic pressure \> 140 or diastolic pressure \> 90
* Baseline heart rate \> 100 bpm or \< 50 bpm
* History of major psychiatric illness
* History of drug/alcohol abuse or current tobacco use
* Vulnerable populations including pregnant or nursing women, the incarcerated, or individuals with severe cognitive disorders
* History of allergic reaction or contraindication to icariin
* Baseline QIDS score \> 7, current suicidal ideation, or history of suicide attempt
* Education history that includes Special Education or history of mental disability
* Clinically significant abnormalities on baseline labs and ECG results
* Current participation in any other pharmacotherapy studies
18 Years
50 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Sherwood Brown
Professor
Principal Investigators
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E. Sherwood Brown, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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102012-052
Identifier Type: -
Identifier Source: org_study_id
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