CEQUEL-FA: Comparative evaluation of quetiapine plus lamotrigine vs quetiapine monotherapy, and folic acid vs placebo

Lead Research Organisation: University of Oxford
Department Name: Psychiatry

Abstract

People with bipolar depression have considerable unmet treatment needs whcih means that they often suffer from continuing symptoms and disability. For the first time, promising drug treatments are now emerging, but we need to know how they can best ben used to help people. We will do a randomised clinical trial investigating the combination of quetiapine and lamotrigine which will help clinicians and patients to choose the best treatment for depressive symptoms in bipolar disorder. We will also investigate the possibility that folic acid - a naturally occurring vitamin - will improve symptoms

Technical Summary

CEQUEL-FA is a randomised controlled trial investigating the efficacy of combination lamotrigine plus quetiapiane in people with bipolar depression. The trial is a 2x2 factorial design with patients additionally being randomised to folic acid or placebo. The trial outcomes are remission from depressive symptoms at 12 weeks and maintenance of improvement by 12 months. A number of secondary analyses will be conducted which should yield valuable knowledge about the neurobiology of folic acid in mood disorders.

The results of CEQUEL-FA will guide therapy for people with bipolar disorder for many years to come and will inform the development of future clinical practice guidelines

Publications

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Cipriani A (2010) Olanzapine in the long-term treatment of bipolar disorder: a systematic review and meta-analysis. in Journal of psychopharmacology (Oxford, England)

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Cipriani A (2009) What is a randomised controlled trial? in Epidemiologia e psichiatria sociale

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Geddes JR (2013) Treatment of bipolar disorder. in Lancet (London, England)

 
Description Course on RCTs
Geographic Reach Multiple continents/international 
Policy Influence Type Influenced training of practitioners or researchers
Impact Regular course in collaboration with Centre for Statistics in Medicine, NPEU and UK Cochrane Centre
 
Description OSCHR Review of Mental Health Research
Geographic Reach National 
Policy Influence Type Participation in advisory committee
Impact Impact on research strategy
 
Description MRC Research Grant (HSPHRB)
Amount £418,829 (GBP)
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 02/2007 
End 02/2009
 
Description NIHR Programme Grants for Applied Research
Amount £1,580,921 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2009 
End 06/2015
 
Description Stanley Medical Research Institute (SMRI)
Amount £1,000,000 (GBP)
Organisation Stanley Medical Research Institute (SMRI) 
Sector Charity/Non Profit
Country Global
Start 03/2009 
End 04/2012
 
Description Strategic Awards
Amount £1,470,000 (GBP)
Funding ID 102616/Z/13/Z 
Organisation Wellcome Trust 
Sector Charity/Non Profit
Country United Kingdom
Start 03/2014 
End 04/2016
 
Title SMS outcome assessment 
Description We have validated the method of capturing the primary outcome using text messages - this has now been implemented in the NHS for routine collection of outcomes. 
Type Of Material Database/Collection of Data/Biological Samples 
Year Produced 2008 
Provided To Others? Yes  
Impact Won national NHS Live prize for innovation 2008 
 
Title True Colours 
Description True Colours is an online self-management system that allows the patient to monitor symptoms and experiences using text, email and the internet. By answering questionnaires the patient creates a record of how they are feeling and can see how it changes over time. True Colours can be used help self-manage health and to share information with family, friends or care team. Data are stored on a secure computer system. 
Type Support Tool - For Medical Intervention
Current Stage Of Development Early clinical assessment
Year Development Stage Completed 2013
Development Status Under active development/distribution
Clinical Trial? Yes
Impact New system for capturing PROMS that is being deployed throughout Oxford and via Oxford AHSN and AHSC 
URL https://truecolours.nhs.uk/www/
 
Description Post-graduate lecture 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Primary Audience Health professionals
Results and Impact Lecture plus questions on contect and design of research

Recruited investigators Changed clinical practice
Year(s) Of Engagement Activity 2007,2008,2009
 
Description Radio and newspaper interviews 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact Several radio interviews

Generated further interest in public
Year(s) Of Engagement Activity Pre-2006,2006,2007,2008,2009,2010,2011,2012,2013,2014