depression and stress axis
Conditions
Interventions
None listed
Sponsors
Organon Nederland BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-45 years (extremes included) at Screening; 2. A body mass index (BMI) of 18-28 kg/m2 (extremes included). 3. (History of) good physical and mental health as determined by history taking, physical and laboratory examinations, ECG and vital signs recordings; 4. Able and willing to sign the Informed Consent Form prior to screening evaluations; 5. Able to refrain from all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) during the stay at the CHDR clinic; 6. Able to refrain from strenuous physical exercise from 48-hours prior to each dosing until dismissal from the CHDR clinic; 7. Smoke less than 5 cigarettes or equivalent per day (amount to be registered) and capable of not smoking during the study days. 8. Females of child bearing potential should use either hormonal contraception in combination with a barrier method (condom, or diaphragm with spermicide), an IUD, or abstinence for the duration of the trial. If the partner is vasectomized an additional barrier method must be used. Males should use any measure to prohibit a pregnancy (vasectomy, a barrier method, or abstinence).
Exclusion criteria
Exclusion criteria: 1. History of drug sensitivity; 2. Use of any drug or substance within one week prior to the first dosing, except for paracetamol and some topical medication (as to judgment of the investigator); 3. Clinically relevant history, family history or presence of any medical disorder, potentially interfering with this trial, - in particular hypercoagulability demonstrated by either known coagulation factor deficiencies (e.g. Factor V Leiden mutation, APC resistance) or previous pulmonary embolism/deep venous thrombosis, arterial thromboembolism, other (arterial) cardiovascular diseases, diabetes insipidus, renal diseases, polydypsia -, or its risk factors; 4. ADAMTS13 deficiency; 5. Personal history of, or parents, children, brothers or sisters with, a psychiatric disease; 6. Subjects with disturbed day/night rhythm due to e.g. working in night-shifts or traveling over time zones within 3 weeks prior to the first dose; 7. History of or current abuse of drugs or alcohol (mean intake of more than 4 units per day) or solvents. 8. Positive drug (at screening and/or admission) or alcohol screen (at screening). 9. Positive test result on hepatitis B surface antigen or hepatitis C antibodies; 10. Positive test result on HIV 1/2 serology; 11. Participation in an investigational drug study within 90 days prior to the first dose; 12. Donation of blood within 90 days prior to the first dose; 13. Pregnancy as confirmed by positive pregnancy test at screening and admission or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: 1. dDAVP 2. human CRH Pharmacodynamics: 1. ACTH 2. total and free cortisol | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. to evaluate the safety of dDAVP and hCRH injections 2. to bank DNA, extracted from blood samples, for future association studies of genotype with the pharmacokinetic, pharmacodynamic and safety characteristics obtained in this trial 3. to obtain results of questionnaires on mood, anxiety state and personality structure for future analysis of these psychological characteristics in relation to HPA axis sensitivity. | — |
Countries
Netherlands
Outcome results
None listed