Acetaminophen for Mood and Memory Changes Associated With Prednisone Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rey Auditory Verbal Learning Test (RAVLT)
研究概览
简要总结
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.
详细描述
SCIENTIFIC PROPOSAL
Aims Primary
- Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller declines in declarative memory than those receiving placebo.
- Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller increases in manic/hypomanic symptoms than those receiving placebo.
Secondary
- Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller declines in cognitive domains other than declarative memory such as working memory and executive functioning than those receiving placebo.
- Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller increases in depressive symptoms than those receiving placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acetaminophen
Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days.
干预措施: Drug: Acetaminophen, Drug: Placebo (Drug)
Placebo
Participants will be given an identical appearing placebo (two 500 mg tablets) four times daily for 7 days.
干预措施: Drug: Acetaminophen, Drug: Placebo (Drug)
结局指标
主要结局
Rey Auditory Verbal Learning Test (RAVLT)
时间窗: Baseline
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.
Rey Auditory Verbal Learning Task (RAVLT)
时间窗: Exit (Day 3 or Day 7)
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.
Hamilton Rating Scale for Depression (HRSD-17)
时间窗: Exit (Day 3 or Day 7)
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+).
Young Mania Rating Scale (YMRS)
时间窗: Exit (Day 3 or Day 7)
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).
Hamilton Rating Scale for Depression (HRSD-17)
时间窗: Baseline
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+).
Young Mania Rating Scale (YMRS)
时间窗: Baseline
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).
次要结局
- 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))
- Internal State Scale - Activation (ISS-ACT)(Baseline)