2024-518226-32-00招募中4 期
Reward-specific changes of cerebral dopamine synthesis in healthy volunteers and depressed patients
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reward-specific changes of dopamin-synthesis
研究概览
简要总结
- Identifying reward-specific alterations in dopamine synthesis (PET) in the nucleus accumbens (NAcc) in patients with MDD compared to healthy volunteers applying the Monetary Incentive Delay Task
- To assess the effect of two different antidepressant agents (escitalopram, bupropion) on reward consumption and reward-specific NAcc dopamine synthesis rates in patients with MDD in a longitudinal design
- To assess the relationship between reward-specific NAcc dopamine synthesis and treatment response in MDD
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged between 18-65 years of age
- •Healthy subjects: HDRS29 ≤ 8, MADRS ≤ 6 and BDI-II < 13
- •Depressive patients: DSM-IV diagnosis of MDD following SCID I, HDRS29, MADRS and BDI-II
- •Satisfactory general health as determined by past medical history, physical examination, vital signs at screening
- •Vital signs measured after 3 minutes resting in the supine position must be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mm Hg, pulse rate 40-100 bpm
- •Subjects must weigh 50-100 kg to participate in this study with a BMI within 19-
- •Sufficient visual and auditory performance for neuropsychological testing
- •Written informed consent will be obtained prior to the start of any study procedures. Therefore, willingness and competence to sign the informed consent form is needed.
- •Potential patients must be able to communicate well with the investigator and comply with the requirements of the study
- •Only participants who are legally authorized to give informed consent will be included in the present study.
排除标准
- •Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity
- •Previous escitalopram- or bupropion intake
- •Antidepressive trials wit DBS, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine
- •Current smoking, substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to DSM-IV
- •Failure to comply with the study protocol or follow the instructions of the investigators
- •Positive urine pregnancy test
- •Known pregnancy or lactation
- •MRI scan that shows evidence of stroke, infarct, or other space-occupying lesion or structural abnormality
- •History of any other drug or alcohol abuse or misuse
- •Participation in any clinical investigation within 12 weeks prior to dosing
- •Evidence from an Allen test of incomplete communication between the radial and ulnar artery, in either hand
- •Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease
- •Significant radiation exposure (>5 mSv) in the frame of participation in trials within the past 10 years
- •Presence of psychotic symptoms
- •Acute suicidality
- •Any contraindication for magnetic resonance or PET imaging
- •Presence of any metallic implant in the head
- •History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to one of the study drugs or multiple study drugs (known hypersensitivity to bupropion, escitalopram)
- •Other clinically significant abnormality on physical, neurological, or laboratory examination or on electrocardiogram (ECG) that, in the opinion of the investigator precludes the patient from the study
- •Prior therapy with antidepressants or other psychotropic agents (depressed patients: ingestion of antidepressants or other psychotropic agents within the last 6 months)
结局指标
主要结局
Reward-specific changes of dopamin-synthesis
Reward-specific changes of dopamin-synthesis
次要结局
- To analyze the relationship between reward-specific dopamine synthesis and fMRI activation across healthy volunteers and patients with MDD
- To identify remission rates in MDD patients being treated with either escitalopram OR bupropion in a longitudinal design
- Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers
研究者
Department of Psychiatry and Psychotherapy, Division of General Psychiatry
Scientific
Medical University Of Vienna
研究点 (1)
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