Theophylline for Depression Study
关键词
抽象
日期
最后验证: | 02/29/2020 |
首次提交: | 03/09/2020 |
提交的预估入学人数: | 03/11/2020 |
首次发布: | 03/15/2020 |
上次提交的更新: | 03/11/2020 |
最近更新发布: | 03/15/2020 |
实际学习开始日期: | 02/29/2020 |
预计主要完成日期: | 05/31/2020 |
预计完成日期: | 05/31/2020 |
状况或疾病
干预/治疗
Drug: Theophylline ER
Other: PO placebo
Biological: Lipopolysaccharide (LPS)
Other: IV placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: PO theophylline & IV LPS Oral (PO) theophylline 400 mg/day for 2 weeks followed by a single intravenous (IV) bolus of lipopolysaccharide (LPS) 0.8 ng/kg of body weight | |
Experimental: PO placebo & IV LPS PO methylcellulose (placebo) daily for 2 weeks followed by a single intravenous (IV) bolus of lipopolysaccharide (LPS) 0.8 ng/kg of body weight | |
Experimental: PO theophylline & IV placebo PO theophylline 400 mg/day for 2 weeks followed by a single IV bolus of 0.9% saline | |
Placebo Comparator: PO placebo & IV placebo PO methylcellulose (placebo) daily for 2 weeks followed by a single IV bolus of 0.9% saline |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - in good general health (as evaluated during the phone and in-person screening sessions) - aged 18-65 years - if female, using adequate birth control Exclusion Criteria: - history of hypersensitivity to xanthine derivatives (a contraindication to theophylline treatment) - pregnant or planning to become pregnant in the next 6 months - current breastfeeding - chronic diseases such as cardiovascular disease, hepatic impairment, peptic ulcer disease, and seizure disorders - current use of prescription medications such as steroids, non-steroid anti-inflammatory drugs, immune modifying drugs, opioid analgesics, and psychotropics - Axis I psychiatric disorders including current major depressive disorder - current depressive symptoms assessed by the Patient Health Questionnaire (PHQ-9 ≥ 5) - heavy smoking (1 pack or more per day) - excessive caffeine use (>600 mg/day) - Body-mass index > 35 due to the effects of obesity on cytokine activity - evidence of recreational drug use from urine test - evidence of pregnancy from urine test - evidence of clinically significant rhythm abnormality on a resting electrocardiogram (ECG) - clinically significant abnormalities on screening laboratory tests |
结果
主要结果指标
1. Change in depressed mood from baseline [At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration]
次要成果指标
1. Change in tension/anxiety from baseline [At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration]
2. Change in depressive symptoms from baseline [At baseline and then at 2, 4, and 6 hours after LPS (or saline) administration]
3. Change in feelings of social disconnection from baseline [At baseline and then at 2, 4, and 6 hours after LPS (or saline) administration]
4. Change in fatigue from baseline [At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration]
5. Change in confusion from baseline [At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration]
6. Change in verbal memory from baseline [At baseline and then 3 hours after LPS (or saline) administration]
7. Change in visual memory from baseline [At baseline and then 3 hours after LPS (or saline) administration]
8. Change in executive function from baseline [At baseline and then 3 hours after LPS (or saline) administration]
9. Change in attention from baseline [At baseline and then 3 hours after LPS (or saline) administration]
其他成果措施
1. Subjective Sensitivity to Social Rejection [2 hours after LPS (or saline) administration]
2. Negative Bias in Facial Emotion Recognition [2 hours after LPS (or saline) administration]
3. Reward [2 hours after LPS (or saline) administration]
4. Change in proinflammatory cytokines from baseline [At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration]
5. Change in kynurenine Metabolites from baseline [At baseline and then at 1, 1.5, 2, 3, 4, 5, and 6 hours after LPS (or saline) administration]
6. Change in gene expression from baseline [At baseline and 30 minutes after LPS (or saline) administration]