Experimentally Evaluating the Hypothesized Mechanism of Action of N-acetylcysteine for Bipolar Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy
研究概览
简要总结
This research study evaluates the effects of anFDA-approved medication NAC in individuals with Bipolar Disorder. Participants in the study will will be assigned to two medication conditions and will take both NAC and a matched placebo. The order in which they take each medication will be random. Study medication will be taken for 14 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-60 years
- •Meet DSM-5 criteria for bipolar I or II disorder
- •Able to provide informed consent and read, understand, and accurately complete assessment instruments
- •Willing to commit to medication treatment and follow-up assessments
- •Meets DSM-5 criteria for any mood episode (i.e., Major Depressive, Hypomanic, Manic), Current or In Partial Remission
- •Prescribed daily use of at least one FDA-approved mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, 2nd generation antipsychotic)
- •Willing to abstain from antioxidant supplements (e.g., coenzyme Q-10, vitamin E) for the duration of the study.
排除标准
- •A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
- •Meet DSM-5 criteria for substance use disorder (other than Tobacco Use Disorder) within the past 6 months.
- •Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
- •Any history of brain injury with loss of consciousness greater than 5 minutes
- •Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
- •Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
- •Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
- •Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
- •Concomitant use of nitroglycerine, carbamazepine, or any other medication deemed to be hazardous if taken with N-Acetylcysteine (NAC).
- •Medication dose changes of ≥ 20% ≤ 2 weeks prior to testing
- •Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
- •Current suicidal or homicidal risk
- •Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
- •Has taken NAC in the last month or experienced adverse effects/allergic reaction from it at any time
- •Significant claustrophobia and/or past negative experiences with MRI
- •Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
研究组 & 干预措施
Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule
Group A will receive NAC 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive Placebo Oral Capsule 2 times a day for 14 days and have another MRI exam on day 14.
干预措施: N-Acetyl cysteine (Drug)
Group A: N-Acetylcysteine, then Washout, then Placebo Oral Capsule
Group A will receive NAC 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive Placebo Oral Capsule 2 times a day for 14 days and have another MRI exam on day 14.
干预措施: Placebo (Drug)
Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine
Group A will receive Placebo Oral Capsule 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive NAC 2 times a day for 14 days and have another MRI exam on day 14.
干预措施: N-Acetyl cysteine (Drug)
Group B: Placebo Oral Capsule, then Washout, then N-Acetylcysteine
Group A will receive Placebo Oral Capsule 2 times a day for a total of 14 days. On Day 14 they will have a Magnetic Resonance Imaging (MRI) exam. They will then have a 14 day washout period. They will then receive NAC 2 times a day for 14 days and have another MRI exam on day 14.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in dACC GSH Levels Through Proton Magnetic Resonance Spectroscopy
时间窗: Day 14 of each experimental condition
Brain GSH levels, balanced with water and CSF-corrected, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy
次要结局
未报告次要终点
研究者
James J. Prisciandaro
Associate Professor
Medical University of South Carolina