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

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ClinicalTrials.gov Identifier: NCT00377364
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : January 16, 2014
Last Update Posted : May 5, 2016
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Asthma
Rheumatic Disease
Intervention Drug: Drug: Acetaminophen, Drug: Placebo
Enrollment 30
Recruitment Details This randomized, double-blind, placebo-controlled study was conducted at asthma and allergy clinics on the UT Southwestern Medical Center campus.
Pre-assignment Details Those with prior psychiatric symptoms during corticosteroid therapy were not excluded.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description OTC pain reliever.fever reducer that may have neuroprotective effects. Matching Placebo.
Period Title: Overall Study
Started 16 14
Completed 14 14
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             1             0
Arm/Group Title Acetaminophen Placebo Total
Hide Arm/Group Description OTC pain reliever.fever reducer that may have neuroprotective effects. Matching Placebo. Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
46.4  (10.4) 39.8  (11.6) 43.3  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
10
  62.5%
12
  85.7%
22
  73.3%
Male
6
  37.5%
2
  14.3%
8
  26.7%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
American Indian or Alaska Native
1
   6.3%
0
   0.0%
1
   3.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  62.5%
8
  57.1%
18
  60.0%
White
4
  25.0%
3
  21.4%
7
  23.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   6.3%
3
  21.4%
4
  13.3%
[1]
Measure Description: Race as self reported by participants
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Rey Auditory Verbal Learning Test (RAVLT)
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: words
44.8  (4.7) 44.1  (9.3)
2.Primary Outcome
Title Rey Auditory Verbal Learning Task (RAVLT)
Hide Description 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.
Time Frame Exit (Day 3 or Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT defined as any post baseline visit. Last Observation Carried Forward.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: words
44.9  (10.9) 44.9  (11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Placebo
Comments Baseline RAVLT scores used as covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Hamilton Rating Scale for Depression (HRSD-17)
Hide Description 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+).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.3  (6.5) 13.4  (8.6)
4.Primary Outcome
Title Hamilton Rating Scale for Depression (HRSD-17)
Hide Description 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+).
Time Frame Exit (Day 3 or Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT defined as any post baseline visit. Last Observation Carried Forward.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever.fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.3  (6.5) 10.3  (8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Placebo
Comments Baseline HRSD scores used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.8  (2.2) 6.1  (5.4)
6.Primary Outcome
Title Young Mania Rating Scale (YMRS)
Hide Description 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).
Time Frame Exit (Day 3 or Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT defined as any post baseline visit. Last Observation Carried Forward.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever.fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.9  (5.8) 5.6  (5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments Baseline YMRS scores used as a covariate.
7.Secondary Outcome
Title Internal State Scale - Activation (ISS-ACT)
Hide Description Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
58.0  (53.8) 109.6  (82.3)
8.Secondary Outcome
Title Internal State Scale - Activation (ISS-ACT)
Hide Description Activation subscale assesses (hypo)manic symptoms. There are 16 questions on the total ISS, each rated on a series of visual analogue scale (VAS) items consisting of statement followed by a 100 mm line with anchor points at 0 and 100. The 16 questions divide into four subscales measuring activation; depression, global psychopathology, and well being. Depression Index (DI): Scores for items 7 and 9 are added to give a DI score ranging from 0-200 with 0 being absence of depressive symptoms and 200 indicating severe depressive symptoms. Well-Being Index (WB): Scores for items 3, 5 and 15 are added to give a WB score ranging form 0-300, with >125 indicating euthymia. Activation Index (ACT): Scores for items 6, 8, 10, 12 and 13 are added to give an ACT score ranging from 0-500, with >155 indicating mania. Perceived Conflict Index (PC): Scores for items 1, 2, 4, 11 and 14 are added to give a PC score ranging from 0-500, with higher scores indicating greater severity of psychopathology.
Time Frame Exit (Day 3 or Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT defined as any post baseline visit. Last Observation Carried Forward.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
93.5  (98.2) 107.8  (121.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments Baseline ISS scores used as a covariate. ANCOVA results were not significant.
9.Secondary Outcome
Title Asthma Control Questionnaire (ACQ)
Hide Description This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.1  (1.0) 3.3  (1.3)
10.Secondary Outcome
Title Asthma Control Questionnaire
Hide Description This is a seven item assessment of symptoms pertinent to asthma management, including day and nighttime symptoms; activity limitation; use of prn bronchodilators; a physiological measure of asthma (spirometry), forced expiratory volume in 1 second percent predicted (FEV1% predicted), which is the percentile of FEV1 compared to normal controls matched for age, height, gender, and race, in the scoring. Total mean is interpreted on a scale between 0 (asthma completely controlled) and 6 (asthma severely uncontrolled).
Time Frame Exit (Day 3 or Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT defined as any post baseline visit. Last Observation Carried Forward.
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:
OTC pain reliever and fever reducer that may have neuroprotective effects.
Matching Placebo.
Overall Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.9  (1.6) 1.7  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments Baseline ACQ scores used as a covariate.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description OTC pain reliever.fever reducer that may have neuroprotective effects. Matching Placebo.
All-Cause Mortality
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: E.Sherwood Brown, M.D., Ph.D.
Organization: UT Southwetern Medical Center at Dallas
Phone: 214-645-6950
EMail: Sherwood.Brown@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00377364     History of Changes
Other Study ID Numbers: 022006-009
First Submitted: September 14, 2006
First Posted: September 18, 2006
Results First Submitted: August 19, 2011
Results First Posted: January 16, 2014
Last Update Posted: May 5, 2016