drugset / Trial / NCT02347033

Trial of Sertraline Versus Cognitive Behaviour Therapy for Generalised Anxiety

NCT02347033

RandomizedParallel-groupOpen-labelTreatment

Summary

Generalised Anxiety Disorder (GAD) is common, causes unpleasant symptoms and impairs people's functioning. It is often chronic and may be accompanied by depression and other anxiety disorders. It is not currently clear whether medication or psychological therapy provides better long term outcomes for those not responding to simpler low intensity treatments so we propose to compare the clinical effectiveness of a pharmacological treatment (the drug Sertraline) with a Cognitive Behavioural Therapy (CBT) intervention. Our hypothesis is that in people with GAD who have not responded to low intensity psychological interventions, CBT will lead to a greater improvement in their GAD symptoms as measured using the GAD-7 scale at 12 month follow-up than Sertraline.

Timeline

Start
2014-08
Primary completion
2016-02
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Sertraline Small molecule 50 mg
Comparator Sertraline Small molecule 100 mg
Comparator Sertraline Small molecule 150 mg