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Trial record 14 of 107 for:    PHENYTOIN

Phenytoin for Memory Impairment Secondary to Megestrol

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ClinicalTrials.gov Identifier: NCT02595723
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
The Rogosin Institute
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Drug: Phenytoin Drug: Megestrol Acetate Drug: Placebo Early Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phenytoin for Memory Impairment Secondary to Megestrol
Study Start Date : July 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Phenytoin + Megestrol
Participants will take phenytoin (200mg BID) for four days and megestrol acetate (800mg/d) for three days following single day of only phenytoin. Declarative memory will be tested on Day 4.
Drug: Phenytoin
Phenytoin is in a class of medications called anticonvulsants. It works by decreasing abnormal electrical activity in the brain.
Other Name: Dilantin

Drug: Megestrol Acetate
Megestrol Acetate is a frequently prescribed medication that is used to stimulate appetite in HIV patients. It is also used for cancer patients and in the elderly, particularly nursing home patients who may be at risk for cognitive impairment or delirium.
Other Name: Megace

Experimental: Placebo + Megestrol
Participants will take placebo for four days and megestrol acetate (800mg/d) for three days following single day of only placebo. Declarative memory will be tested on Day 4.
Drug: Megestrol Acetate
Megestrol Acetate is a frequently prescribed medication that is used to stimulate appetite in HIV patients. It is also used for cancer patients and in the elderly, particularly nursing home patients who may be at risk for cognitive impairment or delirium.
Other Name: Megace

Drug: Placebo
Inactive ingredient matching the active medication in appearance
Other Name: Sugar-pill

Placebo Comparator: Placebo + Placebo
Participants will take placebo for four days and placebo for three days following single day of only placebo. Declarative memory will be tested on Day 4.
Drug: Placebo
Inactive ingredient matching the active medication in appearance
Other Name: Sugar-pill




Primary Outcome Measures :
  1. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 4 visits ]
    RAVLT evaluates a wide diversity of functions, including short-term auditory-verbal memory, and retention of information.


Secondary Outcome Measures :
  1. Digit Span Backwards [ Time Frame: 4 visits ]
    The Digit Span Backwards is a numbers memory test.

  2. The Sternberg Memory Task (SMT) [ Time Frame: 4 visits ]
    SMT is a computer test that measures recognition memory for letters.

  3. The Running Memory Continuous Performance Task (RMCPT) [ Time Frame: 4 visits ]
    RMCPT is a computer test that measures your working memory.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595723


Locations
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United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
The Rogosin Institute
Investigators
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Principal Investigator: E. Sherwood Brown, MD, PhD UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02595723     History of Changes
Other Study ID Numbers: 032015-004
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Phenytoin
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers