Acetaminophen (Tylenol) for Mood and Memory Changes Associated With Corticosteroid Therapy

NCT00377364 | Completed Phase 4 Results

• 1 other identifier: 022006-009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Studies in humans and animals support that stress and/or elevations in corticosteroids lead to changes in hippocampal structure and functioning. This is important as patients with major depression frequently have elevated cortisol, and millions of patients receive prescription corticosteroids (e.g. prednisone). Both depression and corticosteroid therapy are associated with memory impairment and hippocampal atrophy. Our research uses corticosteroid-treated patients to explore interventions that might protect the brain from the effects of stress or corticosteroids. We propose to give 30 corticosteroid-treated asthma patients acetaminophen or placebo. Between group differences in mood, memory and other neurocognitive measures will serve as outcome measures.

Conditions

Asthma; Rheumatic Disease

Keywords

Acetaminophen; corticosteroids; prednisone

Outcome Measures

Primary Outcomes (6)

• Rey Auditory Verbal Learning Test (RAVLT)

  This is a measure of declarative memory (associated with the hippocampus). The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.

  Baseline

• Rey Auditory Verbal Learning Task (RAVLT)

  This is a measure of declarative memory (associated with the hippocampus), using the mean number of words (0-75) recalled from Trials I-V of the RAVLT ± the standard deviation. The assessement was conducted using the same procedures as at baseline. RAVLT total score of ≥ 40 words on trials 1-5(from a range of 0 to 75 words possible)suggests relatively normal memory prior to prednisone therapy.

  Exit (Day 3 or Day 7)

• Hamilton Rating Scale for Depression (HRSD-17)

  The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).

  Baseline

• Hamilton Rating Scale for Depression (HRSD-17)

  The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).

  Exit (Day 3 or Day 7)

• Young Mania Rating Scale (YMRS)

  This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).

  Baseline

• Young Mania Rating Scale (YMRS)

  This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).

  Exit (Day 3 or Day 7)

Secondary Outcomes (4)

• Internal State Scale - Activation (ISS-ACT)

  Baseline

• Internal State Scale - Activation (ISS-ACT)

  Exit (Day 3 or Day 7)

• Asthma Control Questionnaire (ACQ)

  Baseline

• Asthma Control Questionnaire

  Exit (Day 3 or Day 7)

Study Arms (2)

Acetaminophen

EXPERIMENTAL

Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days.

Drug: Drug: Acetaminophen, Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will be given an identical appearing placebo (two 500 mg tablets) four times daily for 7 days.

Drug: Drug: Acetaminophen, Drug: Placebo

Interventions

Drug: Acetaminophen, Drug: Placebo DRUG

Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days

Also known as: Tylenol

Acetaminophen; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• Scheduled to receive at least 20 mg/day of prednisone for at least 7 days
• Baseline Rey Auditory Verbal Learning Test (RAVLT) total score of ≥40

You may not qualify if:

• History of allergic reaction or other contraindication to acetaminophen therapy
• Acetaminophen use within 24 hours of study entry
• History of liver disease or alcohol use of greater than 3 drinks/day
• Severe or unstable medical condition (e.g., recent myocardial infarction,renal failure, diabetes with poor glycemic control)
• Pregnant or lactating female
• Patient has mental retardation, dementia, or other severe cognitive disorder

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: collaborator

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Asthma; Rheumatic Diseases

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Limitations include the small sample size and relatively small changes in mood and memory in both groups that limited our ability to detect between-group differences.

Results Point of Contact

• Title: E.Sherwood Brown, M.D., Ph.D.
• Organization: UT Southwetern Medical Center at Dallas

Sherwood.Brown@utsouthwestern.edu

214-645-6950

Study Officials

• Edson S Brown, M.D., PhD

  UT Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 5, 2016
• Results First Posted: January 16, 2014

Record last verified: 2016-04

Locations

US (1)