Clinical Trial: Lithium Versus Quetiapine in Treatment Resistant Depression

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Pragmatic Trial Comparing the Clinical and Cost Effectiveness of Lithium and Quetiapine Augmentation in Treatment Resistant Depression

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 is due to start in November 2016. Recruitment will begin in London, followed by additional sites in Newcastle and Oxford in early 2017.

Detailed Summary: 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 1:1 at baseline to the decision to prescribe either lithium or quetiapine, and treatment will then be undertaken by clinicians on a real world basis. The acute phase of treatment (8 weeks post-randomisation) will be conducted by trial clinicians with a decision as to then continue treatment as per standard care thereafter. 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 (QID-SR) over 12 months.
Sponsor: King's College London

Current Primary Outcome:

  • Longitudinal depressive symptom severity [ Time Frame: 52 weeks ]
    QIDS-SR
  • Difference in time to all-cause treatment discontinuation [ Time Frame: 12 months ]
    The difference in the time at which patients stop taking the medication for any reason between the two treatment arms.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in clinician rated depression severity [ Time Frame: From baseline to weeks 8 and 52 ]
    MADRS
  • Response rates [ Time Frame: 8 weeks and 52 weeks ]
    Assessed using the MADRS questionnaire
  • Remission rates [ Time Frame: 8 and 52 weeks ]
    Assessed using the MADRS questionnaire
  • Health related quality of life [ Time Frame: Measured at 8 and 52 weeks ]
    Assessed using the EuroQol-5D questionnaire
  • Social functioning [ Time Frame: Measured at baseline, 8 and 52 weeks ]
    Measured using the WSAS self rated questionnaire
  • Adherence to treatment [ Time Frame: Measured at weeks 8 and 52 ]
    Assessed using the MARS-5 questionnaire
  • Change in weight in kilograms [ Time Frame: Measured at 8 and 52 weeks ]
  • Change in diastolic blood pressure [ Time Frame: Change from baseline to 8 and 52 weeks ]
  • Change in systolic blood pressure [ Time Frame: Change from baseline to 8 and 52 weeks ]
  • Time to uptake of a new intervention [ Time Frame: 12 months ]
  • Time to initiation of treatment [ Time Frame: Up to 12 months ]
  • CGI Global Improvement [ Time Frame: Measured at 8 and 52 weeks ]
  • Side effects [ Time Frame: Measured at 8 and 52 weeks ]
    PRISE
  • Serious Adverse Events [ Time Frame: 52 weeks ]
    Serious adverse events will be monitored and reported throughout the patient's participation in the trial.


Original Secondary Outcome: Same as current

Information By: King's College London

Dates:
Date Received: November 17, 2016
Date Started: December 2016
Date Completion:
Last Updated: December 22, 2016
Last Verified: October 2016