Correction: Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

This correction reports changes in our protocol since its publication. These include changes to authorship and acknowledgements, together with improvements to study design and procedures, and correction of an internal inconsistency. The improvements relate to the exclusion criteria, assessments carried out at screening, and mode of data collection

Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Clinical depression is common, debilitating and treatable; one in four people experience it during their lives. The majority of sufferers are treated in primary care and only half respond well to active treatment. Evidence suggests that folate may be a useful adjunct to antidepressant treatment: 1) patients with depression often have a functional folate deficiency; 2) the severity of such deficiency, indicated by elevated homocysteine, correlates with depression severity, 3) low folate is associated with poor antidepressant response, and 4) folate is required for the synthesis of neurotransmitters implicated in the pathogenesis and treatment of depression.</p> <p>Methods/Design</p> <p>The primary objective of this trial is to estimate the effect of folate augmentation in new or continuing treatment of depressive disorder in primary and secondary care. Secondary objectives are to evaluate the cost-effectiveness of folate augmentation of antidepressant treatment, investigate how the response to antidepressant treatment depends on genetic polymorphisms relevant to folate metabolism and antidepressant response, and explore whether baseline folate status can predict response to antidepressant treatment.</p> <p>Seven hundred and thirty patients will be recruited from North East Wales, North West Wales and Swansea. Patients with moderate to severe depression will be referred to the trial by their GP or Psychiatrist. If patients consent they will be assessed for eligibility and baseline measures will be undertaken.</p> <p>Blood samples will be taken to exclude patients with folate and B12 deficiency. Some of the blood taken will be used to measure homocysteine levels and for genetic analysis (with additional consent). Eligible participants will be randomised to receive 5 mg of folic acid or placebo. Patients with B12 deficiency or folate deficiency will be given appropriate treatment and will be monitored in the 'comprehensive cohort study'. Assessments will be at screening, randomisation and 3 subsequent follow-ups.</p> <p>Discussion</p> <p>If folic acid is shown to improve the efficacy of antidepressants, then it will provide a safe, simple and cheap way of improving the treatment of depression in primary and secondary care.</p> <p>Trial registration</p> <p>Current controlled trials ISRCTN37558856</p

Correction: Folate Augmentation of Treatment – Evaluation for Depression (FolATED): protocol of a randomised controlled trial

Abstract This correction reports changes in our protocol since its publication. These include changes to authorship and acknowledgements, together with improvements to study design and procedures, and correction of an internal inconsistency. The improvements relate to the exclusion criteria, assessments carried out at screening, and mode of data collection.</p

United Kingdom Alcohol Treatment Trial (UKATT): Hypotheses, design and methods

The United Kingdom Alcohol Treatment Trial (UKATT) is intended to be the largest trial of treatment for alcohol problems ever conducted in the UK. UKATT is a multicentre, randomized, controlled trial with blind assessment, representing a collaboration between psychiatry, clinical psychology, biostatistics, and health economics. This article sets out, in advance of data analysis, the theoretical background of the trial and its hypotheses, design, and methods. A projected total of 720 clients attending specialist services for treatment of alcohol problems will be randomized to Motivational Enhancement Therapy (MET) or to Social Behaviour and Network Therapy (SBNT), a novel treatment developed for the trial with strong support from theory and research. The trial will test two main hypotheses, expressed in null form as: (1) less intensive, motivationally based treatment (MET) is as effective as more intensive, socially based treatment (SBNT); (2) more intensive, socially based treatment (SBNT) is as cost-effective as less intensive, motivationally based treatment (MET). A number of subsidiary hypotheses regarding client-treatment interactions and therapist effects will also be tested. The article describes general features of the trial that investigators considered desirable, namely that it should: (1) be a pragmatic, rather than an explanatory, trial; (2) be an effectiveness trial based on 'real-world' conditions of treatment delivery; (3) incorporate high standards of training, supervision and quality control of treatment delivery; (4) pay close attention to treatment process as well as treatment outcome; (5) build economic evaluation into the design at the outset. First results from UKATT are expected in 2002 and the main results in 2003