Xenon als Antidepressivum - Xenon als Antidepressivum

• Conditions: Major depressive disorder and recurrent mayor depressive disorder (ICD 10 F32.2 and 33.3)

• Registration Number: EUCTR2006-005531-17-DE
• Lead Sponsor: Klinik für Anästhesiologie Universitätsklinikum Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-14
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.