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Phenytoin for Memory Impairment Secondary to Megestrol

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ClinicalTrials.gov Identifier: NCT02595723
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
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 200 mg capsule Drug: Megestrol 800 mg liquid Drug: Phenytoin-matched Placebo capsule Drug: Megestrol-matched liquid Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each participant receives three treatments: phenytoin + megestrol, placebo + megestrol, or placebo + placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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, Then Megestrol
Participants first received pretreatment with Phenytoin 200 mg capsule twice/day for one day. Participants then received both Phenytoin (200 mg capsule twice/day) and liquid Megestrol (800 mg/day) for three consecutive days.
Drug: Phenytoin 200 mg capsule
Phenytoin oral capsule was initiated on Day 1 and administered at 200 mg twice/day for four consecutive days (Days 1 - 4).

Drug: Megestrol 800 mg liquid
Liquid megestrol 800 mg/was initiated on Day 2 and administered at 09:00 for three consecutive days (Days 2 - 4).

Experimental: Placebo, Then Megestrol
Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Megestrol (800 mg/day) for three consecutive days.
Drug: Megestrol 800 mg liquid
Liquid megestrol 800 mg/was initiated on Day 2 and administered at 09:00 for three consecutive days (Days 2 - 4).

Drug: Phenytoin-matched Placebo capsule
Phenytoin-matched oral Placebo capsule was initiated on Day 1 and administered for four consecutive days (Days 1 - 4).

Experimental: Placebo, Then Placebo
Participants first received pretreatment with Placebo (matching Phenytoin 200 mg capsule) twice/day for one day. Participants then received both Placebo (matching Phenytoin 200 mg capsule) twice/day and liquid Placebo (matching liquid Megestrol 800 mg/day) for three consecutive days.
Drug: Phenytoin-matched Placebo capsule
Phenytoin-matched oral Placebo capsule was initiated on Day 1 and administered for four consecutive days (Days 1 - 4).

Drug: Megestrol-matched liquid Placebo
Megestrol-matched liquid placebo was initiated on Day 2 and administered at 09:00 for three consecutive days (Days 2 - 4).




Primary Outcome Measures :
  1. Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 4 days after intervention administration ]
    Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. The raw scores on the total recall (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.



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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
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019
Last Verified: September 2019
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