Lithium versus Quetiapine in Depression (LQD study), Version 1
Research type
Research Study
Full title
A randomised pragmatic trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression
IRAS ID
201898
Contact name
Anthony Cleare
Contact email
Sponsor organisation
King's College London
Eudract number
2016-001637-27
ISRCTN Number
ISRCTN16387615
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
There is currently uncertainty about how best to treat patients whose depression has not shown good response to initial antidepressant treatments (“treatment resistant depression” – TRD). There are several effective options for treating TRD, however, few good studies have compared these treatments directly with one another head-to-head and most studies have been short-term (i.e. 6-8 weeks) and have not assessed the longer-term effects of these treatments. A common option for patients and their doctor is to prescribe a different type of medication in addition to an antidepressant (“augmentation”, or “add-on” treatment). We propose to compare the long term effects of lithium and quetiapine augmentation therapy over 12 months to see which medication is most clinically and cost-effective for patients with TRD. This knowledge could benefit future patients and influence clinical guidelines.
It will be a multi-centre study and 276 patients with TRD will receive a decision to prescribe add-on treatment with either quetiapine or lithium chosen at random. Treatment will be guided by current best practice and according to the medications' SmPCs, including dosing and monitoring and be undertaken by clinicians on a real world, open-label basis. Prescribing and monitoring of these medications will be conducted by trial clinicians in the acute phase (8 weeks). Thereafter as per standard care. Patients will be monitored by trial researchers for 12 months, even if they discontinue the treatment, as it is important that we know what happens in real life when these treatments are used and when they are stopped i.e. what happens after the initial decision to prescribe either medication. We will measure how effective the treatments are in terms of depressive symptoms, quality of life, side effects and whether any other treatments were needed. We will also estimate the costs associated with each treatment. The study will run for 4 years.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0318
Date of REC Opinion
20 Sep 2016
REC opinion
Further Information Favourable Opinion