Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02595723 : Phenytoin for Memory Impairment Secondary to Megestrol
PhasePhase 0
AgesMin: 18 Years Max: 50 Years
Eligibility
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02595723      |      Link to official Clinicaltrials.gov listing
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