Acromegalie with depression MedDRA version: 20.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Somavert 20 mg
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: PEGVISOMANT
CAS Number: 218620-50-9
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Max-Planck-Institut für Psychiatrie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate and compare the placebo-controlled depression improvements of Pegvisomant and SSRI Escitalopram in acromegalic patients during 8 weeks of therapy in the three therapeutic arms.;Secondary Objective: The secondary objectives are • to access and compare the placebo-controlled effects of Pegvisomant and SSRI Escitalopram on quality of life during 8 weeks treatment. • to access and compare the placebo-controlled effects of Pegvisomant and SSRI Escitalopram on health outcome during 8 weeks treatment • to access and compare the placebo-controlled effects of Pegvisomant and SSRI Escitalopram on depression severity during 8 weeks treatment. • to access and compare the placebo-controlled effects of Pegvisomant and SSRI Escitalopram on pain experience during 8 weeks treatment. • to access and compare placebo-controlled effect of Pegvisomant and SSRI Escitalopram on metabolic changes during 8 weeks treatment. ;Primary end point(s): The primary variable will be the change in depression score from baseline to 8 weeks measured by the Beck Depression Inventory (BDI-II);Timepoint(s) of evaluation of this end point: after 8 weeks fo therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measure • Changes (?) in the quality of life from baseline to week 8 using AcroQuol and EQ 5D. • Changes (?) in depression severity from baseline to week 8 using Hamilton Rating Scale for Depressoin (HAMD). • Changes in pain experience from baseline to week 8 using the PainDetect. • Changes in blood levels IGF-I, fasting gucose ans HbA1c from baseline to week 8. Safety endpoint: • Changes in QT-Time in ECG according to flow chart ;Timepoint(s) of evaluation of this end point: saftey endpoint weekly, secondary endpoint after 8 weeks of therapy | — |
Countries
Germany
Contacts
Public ContactKathrin Popp
Max-Planck-Institut für Psychiatrie
Outcome results
None listed