Pegvisomant and Escitalopram in acromegalic depressive patients

Phase 1

• Conditions: Acromegalie with depression; MedDRA version: 20.0Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2014-000265-43-DE
• Lead Sponsor: Max-Planck-Institut für Psychiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified