N-acetylcysteine and NMDA Antagonist Interactions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Novel P300
研究概览
简要总结
This study tests the hypothesis that extrasynaptic mechanisms are critically linked with cognitive effects of NMDA antagonism as evidenced by event-related potentials (ERPs) in healthy humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages of 21-45 years from all ethnic backgrounds.
- •Male or female.
- •Written informed consent.
- •Exclusion criteria
- •DSM-IV diagnosis for a psychotic, depressive or anxiety disorder.
- •A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic abnormality, seizure disorder. Unstable medical condition based on EKG, vital signs, physical examination and laboratory work-up (CBC with differential, SMA-7, LFTs, TFTs, UA, Utox, Urine pregnancy test) .
- •History of severe allergies or multiple adverse drug reactions.
- •Any medication that in the opinion of the PI could interfere with either the safety of the study and/or the outcome measures.
- •Any other conditions which in the opinion of the investigator would preclude participation in the study.
- •History of major psychiatric disorder in first degree relatives.
- •Current substance abuse/dependency determined by urine toxicology.
- •Current treatment with medications with psychotropic effects.
- •Treatment with benzodiazepines within one week prior to testing.
- •Current pregnancy, unsatisfactory birth control method report for females.
- •Education < 10th grade.
- •IQ < 70, MR as determined by Wechsler Abbreviated Scale of Intelligence.
- •Non-English speaking.
排除标准
- 未提供
研究组 & 干预措施
Arm I
The NAC capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after NAC administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketamine was administered intravenously as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min (SPM and RVP), and then .29 mg/kg for 40 min (P300 and MMN).
干预措施: N-acetylcysteine and ketamine (Drug)
Arm II
The placebo capsules were administered orally in divided doses: 2000 mg followed by 1000 mg 2 hours later. Each morning, 165 min after placebo administration, subjects received a 1-min bolus of normal saline, followed by a 70-minlong saline infusion during which behavioral, cognitive, and ERP data were collected. Ketamine was administered intravenously as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min (SPM and RVP), and then .29 mg/kg for 40 min (P300 and MMN).
干预措施: placebo and ketamine (Drug)
结局指标
主要结局
Novel P300
时间窗: daily
The Novel P300 measures were obtained from the Fz, Cz and Pz electrodes. Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (\~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL.
Target P300
时间窗: daily
The Target P300 measures were obtained from the Fz, Cz and Pz electrodes. Target stimuli were 1000 Hz tones (500 ms) and novel stimuli (\~250 ms) were unique environmental sounds (e.g., dog bark) used in prior studies of the novelty P300. Subjects were instructed to respond to the target sounds by pressing a button using their dominant hand index finger. The standard stimuli were 20, 30 or 40 Hz click trains (500 ms) in the first, second, and third runs, respectively. The auditory steady state EEG driving data obtained from these standard stimuli will be presented in a separate report. All stimuli were presented at 80 dB SPL.
次要结局
- Mismatch Negativity (MMN) Intensity(daily)
- Mismatch Negativity (MMN) Duration(daily)
- Mismatch Negativity (MMN) Frequency(daily)