Hypothalamic-Pituitary-Adrenal (HPA)/ Dopamine Axis in Psychotic Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Cortisol
研究概览
简要总结
The primary objective of this study is to investigate the relationships among findings in structural and functional neuroimaging, cognitive testing and HPA (hypothalamic-pituitary-adrenal) axis dysregulation in psychotic depression.
详细描述
Eligibility Procedures: Before entering the study and prior to any other procedures, you will be asked to read and sign this consent form. To determine if you are eligible for our study, you will then have a general medical (including menstrual cycle history on female patients) and psychiatric history taken, a physical examination your vital signs (blood pressure, pulse), height, weight, waist/hip ratio will be measured, and various psychiatric evaluations will be conducted. We will be video recording the psychiatric diagnostic assessment of every 5th patient who enrolls in our study.
On Day 1, your mood will be evaluated using a series of commonly used diagnostic instruments and rating scales. We will repeat the medical exam, blood and urine lab tests you had at your initial screening visit if it has been more than 4 weeks (30 days) since your eligibility screening.
The rest of the study includes an MRI, neuropsychological testing, questionnaires, and blood draws.
The MRI (called magnetic resonance imaging, MRI) involves having a picture of your brain taken using a magnet while a series of tasks is administered to you. The MRI scan procedures will take approximately 1 hour.
The neuropsychological testing consists of a series of tests to assess your memory and concentration (neuropsychological means the way your brain processes and completes specific tasks.) This testing, including directions, will take approximately 3 hours of your time. You will also be asked to complete several questionnaires during your hospital stay. These questionnaires ask for your views about your personality, your childhood experiences your quality of life, your mood and a variety of aspects of your daily functioning. The questionnaires may be completed anytime during your stay and will take about 2.5 hours to finish
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for PMD (individuals with Psychotic Major Depression) and NPMDs (individuals with Non-Psychotic Major Depression) are as follows:
- •DSM IV diagnosis of Major Depressive Disorder with or without psychotic features, Bipolar II Disorder with or without psychotic features in a major depressive episode.
- •21-item HAM-D score greater than or equal to
- •Thase Core Endogenomorphic Scale score greater than or equal to 6 on the items included in the 21-item HDRS.
- •Between 21 - 85 years of age.
- •If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
- •Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
- •Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder(OCD) will be an exclusion criteria.
- •Inclusion criteria for healthy controls are as follows:
- •Between 21 - 85 years of age.
- •Taking no medications
- •Have a HAM-D score of less than or equal to 5.
排除标准
- •Exclusion criteria for PMDs and NPMDs are as follows:
- •ECT in the 4 months prior to the study.
- •Abuse of drugs or alcohol in the 6 months prior to study.
- •Unstable or untreated hypertension, or cardiovascular disease.
- •If participating in the blood draw portion of the protocol, endocrine disorders are exclusionary.
- •Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- •Any Axis II diagnosis or traits which would make participation in the study difficult.
- •Current pregnancy or lactation.
- •Exclusion criteria for healthy controls:
- •Personal history of Axis I or Axis II disorders.
- •Active unstable medical problems.
- •Abuse of drugs or alcohol in the 6 months prior to study.
- •Use of additional prescription medications, street drugs, or alcohol during the week before the study.
- •Currently pregnant or lactating.
结局指标
主要结局
Cortisol
时间窗: baseline
Hourly serum cortisol
次要结局
- Cognitive function(Baseline)