EUCTR2014-000265-43-DE进行中（未招募）1 期
A randomized, placebo-controlled trial comparing the treatment effect of Pegvisomant and the SSRI Escitalopram on depressive acromegalic patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Adult patients between 18 and 65 years
- •2)Female and male
- •3)Confirmed diagnosis of acromegaly
- •4)Under stable therapy and stable hormonal substitution for at least three months
- •5)Biochemically controlled acromegaly (confirmed by normal IGF-1 values for age and gender) with side effects of the current medication.
- •6)Psychiatric diagnosis of unipolar depression (according to S3-Leitlinie Nationale Versorgungsleitlinie unipolare Depression) with an BDI-II: 14-19
- •7)Signed informed consent by patient
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Female patients who are pregnant or lactating, or are of childbearing potential as well as men of childbearing potential and not practicing a medically acceptable method of birth control. Women of childbearing potential who are sexually active with opposite partners have to perform adequate contraception with a combination of a highly effective method of birth control and additional barrier contraception. [Highly effective method of birth control is defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly for the entire study duration: combined (oestrogen and gestagen) oral contraceptives, hormone implants, hormone injectables, or hormone containing intrauterine device that needed to be in place for a period of at least 2 months prior to screening. Additional barrier contraception (at least the following methods are allowed: condom of the male, diaphragm with spermicide, portio cap with spermicide) has to be used for the duration of the trial, defined as from the time of screening to the end of double-blind treatment phase. A single barrier method is not acceptable. Women of non-childbearing potential can be included if surgically sterile (documented complete hysterectomy or bi-tubal ligations) or postmenopausal >1 year
- •2.Men of reproductive potential must use condoms. In addition, the female partner should also be on a safe hormonal contraception (e.g. combined oral contraceptives, hormone implant hormone injectables or hormone containing intrauterine device) or use a barrier contraception (e.g. intrauterine device, diaphragm or portio cap with spermicide), if she is of childbearing potential.
- •3.Previous (within last 6 months) or concomitant therapy with antidepressants or PegvisomantConcomitant medication with dopamine agonists
- •4.Patients with epilepsy and increased risk of bleeding
- •5.Patients with the risk of suicide
- •6.Known history of long QT-syndrome, arrhythmias or relevant diseases of the heart
- •7.Suspected or known hypersensitivity to Escitalopram or Pegvisomant
- •8.Any physical condition which interferes with the recommendation in the SMPC of Escitalopram or Pegvisomant (see also not allowed concomitant medication)
- •9.Suspected or known drug or alcohol abuse
- •10.Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
- •11.Participation in another clinical trial
- •12.Planned treatment or changes in established treatment with any other drug which might influence outcome
- •13.Severe disturbances in articulation, visual faculty or hearing
- •14.Any elective surgery or medical treatment planned in the observation period
- •15.Unable to give consent to study participation
- •16.Intensive Care treatment
- •17. Patients with insuline-dependent type 2 diabetes mellitus or type 2 diabetes mellitus with antidiabetic medication with a risk of hypoglycaemia
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