Phenytoin for Memory Impairment Secondary to Megestrol

Completed · Phase 4 · Has a placebo group

Conditions studied: Cognitive Impairment

In brief

This study is designed to test if megestrol acetate induces changes in declarative memory in healthy controls and if pre-administration of phenytoin can ameliorate any induced cognitive impairments.

Key facts

Study ID

NCT02595723

Run by

University of Texas Southwestern Medical Center

People needed

21

Starts

2015-07-01

Expected to finish

2016-12-01

Last updated by the study team

2019-09-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women age 18-50 years
• Education of ≥ 12 years and baseline Rey Auditory Verbal Learning Test (RAVLT) total words recalled score ≥ 40 (normal baseline memory)
• Body mass index (BMI) between 18.5-35
• The ability to read and speak English as not all neurocognitive assessments have been translated and validated in other languages.

You may not qualify if…

• History (lifetime) of Bipolar Disorder, Major Depressive Disorder, psychotic depressive, schizophrenic, schizoaffective, or other Axis I psychotic disorders
• Has an unstable general medical condition (GMC) or significant medical condition, including but not limited to myocardial infarction, cancer, diabetes (hypertension is allowed if condition is being treated and is stable)
• Vulnerable populations including pregnant or nursing women, the incarcerated, or those with severe cognitive disorders
• Education history that includes Special Education or history of mental disability
• History of psychotropic medication therapy in the past 30 days
• Baseline Quick Inventory of Depressive Symptoms-Clinician Rated (QIDS-C) > 5
• Initiation of new medications within 14 days of the baseline visit, with the exception of over-the-counter (OTC) as needed medications (e.g. Tylenol, Advil, Motrin, etc.)
• Significant hypertensive blood pressure at baseline, defined as either systolic pressure > 150 or diastolic pressure > 95
• Febrile at baseline, defined as body temperature ≥ 100.5°F (38°C)
• Baseline heart rate > 100 bpm or < 50 bpm
• Medical history of diseases with central nervous system (CNS)-involvement, including but not limited to stroke, traumatic brain injury, and loss of consciousness > 1 minute
• History of allergic reaction or medical contraindication to megestrol or phenytoin
• Clinically significant abnormalities on baseline labs (e.g. hypokalemia, hypernatremia, anemia)
• Lifetime history of an immunosuppressive disorder or immunosuppressive therapy with within the past 6 months
• History of blood clots such as myocardial infarction (MI), stroke, deep vein thromboses (DVTs), pulmonary embolism (PE) or blood clotting disorder
• Currently actively suicidal or considered a high suicide risk (e.g. more than one lifetime suicide attempt or any attempt in the past 12 months)
• Any reason not listed which, as determined by the principle investigator (PI), would affect participant safety in the study

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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