High dose corticosteroid pulses in treatment-resistant depression : a randomized double-blind placebo-controlled pilot study - Treating Unresponsive Depression – Overcoming Refractoriness

niversity Hospitals Bristol NHS Foundation Trust0 sites40 target enrollmentMarch 25, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 25, 2008

End Date

December 30, 2011

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity Hospitals Bristol NHS Foundation Trust

•Patients will be aged 21\- 75, have DSM\-IV major depression and a Montgomery Asberg Depression Score (MADRS) \>20\. They will not be responding to their current treatment and have failed at least two treatments in the current episode. Patients will be able to give written, informed consent
•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

•History of psychotic symptoms, of reported significant memory impairment, of significant head trauma, of antisocial personality disorder, of alcohol or drug dependence, of hypertension, of duodenal or gastric ulcers, of diabetes, of glaucoma or of cataracts. Current suicidal intent, pregnancy or infection. Past neurosurgery for affective disorders, resistance to ECT, history of mania, resistance to TMS or to Magnetic Stimulation Therapy. Antidepressant medication change within the previous 6 weeks. Patient reports that they have not had chickenpox. Significant abnormalities in baseline physical examination or routine blood tests (FBC, U\&E, LFT, TFT, ESR). Abnormal Fasting Blood Glucose. Weight \<120Kg, BMI \<40\.