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PYRIDOSTIGMINE INDUCED GROWTH HORMONE RESPONSE IN MOOD DISORDERS

PYRIDOSTIGMINE INDUCED GROWTH HORMONE RESPONSE IN MOOD DISORDERS
吡啶斯豆胺诱导情绪障碍中的生长激素反应
批准号:
6220178
负责人:
JONATHAN R SPORN
金额:
$0.06万
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

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中文摘要
翻译
大量研究表明,情感性障碍患者具有胆碱能超敏感。神经内分泌刺激试验使用吡地斯的明来测量它,吡地斯的明增加下丘脑的胆碱能张力,从而释放生长激素。这是一项单独的研究表明,那些可能患有双相情感障碍的患者,在接受了毒豆碱的试验后,他们的思维障碍得到了短暂的改善,他们对锂有反应。我们希望检验情感障碍患者具有胆碱能超敏反应的假设,并确定这种假定的超敏反应是否是反应以及某些人格特征、心理感觉体验和挑战测试结果的标志。迄今为止,已有10名患者入组(3名对照和双相)。研究人员希望对这项研究做出改变。为了让更多不同类型的病人加入我们的治疗方案。研究人员正在提出一项协议修正案,他们希望能够改善受试者的招募。虽然研究者希望通过扩大纳入标准来改变方案,但实际的挑战测试本身将按照原方案进行。修改标准:1;研究人员建议,单极和惊恐障碍患者在第一天每个方案只接受一次挑战测试。通过这样做,接受单药随机临床试验的患者可以在允许的情况下进行这项研究,因为研究人员不知道患者是服用了活性药物还是安慰剂,因此无法对已接受治疗的患者进行重新挑战。2. 研究人员建议再纳入16-30名接受单一疗法而非锂治疗的双相患者。这些双相情感障碍患者将不会再接受挑战,但将在挑战测试后进行四周的监测。3. 这些患者将接受与原始方案相同的筛查,并将通过原始方案的评分量表部分进行检查。按照最初的协议,病人将被送进医院,除了苯二氮卓类药物外,他们没有服用任何精神药物。因此,与原始方案的主要区别在于,单极、恐慌和额外的双相患者在第4周时不会再次受到挑战,而这一额外组的双相患者将接受其他情绪稳定剂(如Depakote)的治疗。
英文摘要
Numerous studies have demostrated that patients with affective disorders have cholinergic supersensitivity. The neuroendocrine challenge test to measure it employs pyridostigmine, which increase cholinergic tone in the hypothalamus, thereby releasing GH. This is a single study indicating that the patients who were probably bipolar and had brief improvement in their thought disorders after a trial with physostigmine, went on to be lithium responders. We wish to test the hypothesis that patients with affective disorders have cholinergic supersensitivity and determine if this supposed supersensitivity is a marker of response as well as certain personality traits, psychosensory experience, and the results of the challenge test. To date 10 patients have been enrolled (3 controls and bipolar). The investigators would like to make changes to this study. In order to allow for a greater variety of patients to enter the protocol. The investigators are proposing an amendment to the protocol that they hope will allow for improved recruitment of subjects. Although the investigators wish to change the protocol by broadening the inclusion criteria, the actual challenge test itself will be performed as per the original protocol. Amendment Criteria: 1. The investigators propose that the unipolar and panic disorder patietns only receive one challenge test per protocol on Day 1. By doing so, patients who are to entger monotherapy randomized clinical trials, where rechallenging of treated pateitns would not be possible as the investigators would not know whether a patient is on active agent or placebo, can have this study "piggy-backed" on where allowed. 2. The investigators propose that 16-30 additional bipolar patients who are to receive monotherapy treatment other than lithium be entered. These bipolar patietns will not be rechallenged, but will be monitored for four weeks after the challenge test. 3. These patients will have the same screening as in the original protocol and will progress though the rating scales portion of the original protocol. Patients will be entered, as per the original protocol, who are not on any psychotropic medications other than benzodiazepines. Thus, the central difference from the original protocol is that unipolar, panic and additional bipolar patients will not be rechallenged at 4 weeks and that bipolar patients in this additional group will be treated with other mood stabilizers (such ad Depakote).
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