Major depressive disorder and recurrent mayor depressive disorder (ICD 10 F32.2 and 33.3)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of both sexes aged > 18 yrs with the diagnosis of major depression (DSM 296.23 and 296.33) and at least two failed treatments with currently available antidepressants. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients < 18 yrs or patients not able to give informed consent for participation in the trial. Patients with a history of cardiovascular (heart failure, coronary heart disease) or pulmonary disease (Asthma, COPD) requiring medication. Furthermore, patients with allergies to xenon or latex and are excluded as well as patients with a positive drug test on admission or signs of dependency. Suspected or proven preganancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of therapeutic effects of xenon in therapy resistant depression;Secondary Objective: Evaluation of side effects;Primary end point(s): Effects of treatment on validated diagnostic tools used for assessing the mood status of depressed patients: (Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI) and the Clinical Global Impression (CGI) Scale. | — |
Countries
Germany