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

Phase 1

• Conditions: Resistant depression; MedDRA version: 8.1 Level: LLT Classification code 10012378 Term: Depression

• Registration Number: EUCTR2006-006089-40-GB
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-25
• Study Completion: 2011-12-30
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary hypothesis we aim to test is that three daily pulses of high dose hydrocortisone will produce an immediate mood elevating effect in people with Treatment Resistant Depression that will translate to an antidepressant effect by week 3. ;<br> Secondary Objective: To study whether those patients who did not respond to the first double-blind treatment regime will respond when given an open trial of hydrocortisone similarly given.<br><br> To study sleep changes during treatment.<br> ;Primary end point(s): Montgomery-Asberg Depression Rating Scale at Day 29