Retinoic Acid Homeostasis in Neuropsychiatric Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum retinoic acid (RA) levels [nM]
研究概览
简要总结
It is hypothesized, that local retinoic acid (RA) homeostasis is functionally involved in the pathophysiology of depression. In a cross-sectional (and partly longitudinal) analysis, serum RA status will be assessed in healthy controls and subjects with Major Depression, Alzheimer's disease, alcoholism and in subjects with schizophrenia.
详细描述
Retinoids comprise of a group of small-molecule derivatives of Vitamin A with retinoic acid (RA) representing the biologically most active endogenous form. RA has multiple functions central nervous system (CNS). It is hypothesized, that local RA homeostasis is functionally involved in the pathophysiology of numerous neuropsychiatric diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •depressive episode in the context of unipolar major depression
- •at least 18 points or more on the BDI and HAMD-17
排除标准
- •additional or comorbid axis-I or axis-II disorder
- •current history of any neurological or other serious medical condition
- •any psychopharmacological treatment or substance use within the last two weeks or 5 half-lives (whichever is longer) of the respective substance
- •any oral or topical application of retinoid-containing preparations within the last 3 months
- •Inclusion Criteria:
- •diagnosed AD
- •Exclusion Criteria:
- •any other neurodegenerative disorder
- •any oral or topical application of retinoid-containing preparations within the last 3 months
- •Schizophrenia-Group
- •Inclusion Criteria:
- •subjects with schizophrenia
- •intended therapy with clozapine, olanzapine or aripiprazole
- •BMI: 18 - 29,9 kg/m2
- •Exclusion Criteria:
- •presence of diabetes or pathological glucose tolerance
- •presence of and chronic inflammatory disease
- •any psychopharmacological treatment of clozapine, olanzapine or aripiprazole within the last 3 months
- •any oral or topical application of retinoid-containing preparations within the last 3 months
- •Alcoholism-Group
- •Inclusion Criteria:
- •subjects with alcoholism who either still consume alcohol or are abstinent for at least 4 weeks
- •Exclusion Criteria:
- •any oral or topical application of retinoid-containing preparations within the last 3 months
- •current history of any neurological or other serious medical condition despite liver diseases
结局指标
主要结局
Serum retinoic acid (RA) levels [nM]
时间窗: Week 0
Serum retinoic acid levels \[nM\] as determined by HPLC according to previously published protocols
次要结局
- For MDD group: MADRS(Week 1, 3, 6)
- For MDD group: BDI II(Week 1, 3, 6)
- For MDD and schizophrenia Group: Change of serum retinoic acid (RA) levels [nM](Week 1, 3, 6)
- For schizophrenia group: Positive and Negative Syndrome Scale (PANSS) for Schizophrenia(Week 1, 3, 6)
- For schizophrenia group: Change of metabolic parametres For schizophrenia group:Positive and Negative Syndrome Scale (PANSS)(Week 1, 3, 6)
研究者
Julian Hellmann-Regen
MD
Charite University, Berlin, Germany