Viewing Study NCT03004521



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Last Modification Date: 2024-10-26 @ 12:15 PM
Study NCT ID: NCT03004521
Status: UNKNOWN
Last Update Posted: 2021-03-05
First Post: 2016-11-17

Brief Title: Lithium Versus Quetiapine in Treatment Resistant Depression
Sponsor: Kings College London
Organization: Kings College London

Study Overview

Official Title: A Randomised Pragmatic Trial Comparing the Clinical and Cost Effectiveness of Lithium and Quetiapine Augmentation in Treatment Resistant Depression
Status: UNKNOWN
Status Verified Date: 2021-03
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LQD
Brief Summary: LQD is a multicentre randomised clinical trial comparing the clinical and cost effectiveness of lithium versus quetiapine when used as add-on therapies to antidepressant medication for patients with treatment resistant depression The Lithium versus Quetiapine in Depression LQD study will assess patients over 12 months to establish which if any treatment is more likely to improve TRD over a long duration of time Professor Anthony Cleare is the Chief Investigator and recruitment began in November 2016
Detailed Description: This 12 month parallel group multi-centre patient randomised pragmatic open label trial is comparing the clinical and cost-effectiveness of the decision to prescribe lithium versus quetiapine add-on treatment to antidepressant medication There will be two parallel groups 1 Quetiapine add-on to existing antidepressant medication 2 Lithium add-on to existing antidepressant medication 276 patients will be randomised 11 at baseline to the decision to prescribe either lithium or quetiapine and treatment will then be undertaken by clinicians on a real world basis All patients regardless of their treatment status will be followed up in the trial for one year This is a superiority design whereby we hypothesise that quetiapine will be superior to lithium in terms of time to treatment discontinuation and average symptom burden QIDS-SR over 12 months

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None