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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精神障碍患者存在胆碱能超敏反应。 神经内分泌激发试验测量它采用吡啶斯的明,增加下丘脑的胆碱能紧张,从而释放生长激素。 这是一项单一的研究,表明那些可能患有双相情感障碍的患者,在接受毒扁豆碱试验后,他们的思维障碍得到了短暂的改善,这些患者继续成为锂盐治疗的应答者。 我们希望检验这一假设,即情感障碍患者具有胆碱能超敏性,并确定这种假定的超敏性是否是反应的标志,以及某些人格特征、心理感觉体验和挑战测试的结果。迄今为止,已入组10例患者(3例对照和双相)。研究者希望对本研究进行变更。 以便允许更多类型的患者进入方案。 研究人员正在对方案提出一项修正案,他们希望能够改善受试者的招募。 尽管研究者希望通过扩大入选标准来变更方案,但实际挑战试验本身将按照原始方案进行。修改标准:1. 研究者建议单相和惊恐障碍患者仅在第1天按照方案接受一次激发试验。 通过这样做,那些将进入单药治疗随机临床试验的患者,在这些试验中,由于研究者不知道患者是使用活性药物还是安慰剂,因此不可能对治疗患者进行再激发,因此可以在允许的情况下“搭载”本研究。2. 研究者建议另外入组16-30例接受锂盐以外单药治疗的双相情感障碍患者。 这些双相情感障碍患者将不接受再激发,但将在激发试验后监测四周。3. 这些患者将接受与原始方案中相同的筛选,并将通过原始方案的评级量表部分进行进展。 根据原始方案,未使用苯二氮卓类药物以外的任何精神药物的患者将入组。 因此,与原始方案的主要差异是,单极、惊恐和其他双相患者在4周时将不会再激发,并且该额外组中的双相患者将接受其他情绪稳定剂(如ad Depakote)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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