Trial of Sertraline Versus Cognitive Behaviour Therapy for Generalised Anxiety

• Status: Terminated
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Collaborators: National Institute for Health Research, United Kingdom; NHS Health Technology Assessment Programme
• Treatments: Serotonin Uptake Inhibitors; Sertraline

Criteria

Inclusion Criteria:

• Aged 18 or above

• Positive score of 10+ on GAD-7

• Primary diagnosis of GAD as diagnosed on MINI

• Failure to respond to NICE defined low intensity psychological interventions

Exclusion Criteria:

• Inability to complete questionnaires due to insufficient English or cognitive impairment;

• Current major depression

• Other comorbid anxiety disorder(s) of more severity or distress to the participant than their GAD;

• Significant dependence on alcohol or illicit drugs;

• Comorbid psychotic disorder, bipolar disorder;

• Treatment with antidepressants in past 8 weeks or any high intensity psychological therapy within past 6 months;

• Currently on contraindicated medication: monoamine oxidase Inhibitors within the past 14 days or pimozide;

• Patients with poorly controlled epilepsy;

• Known allergies to the Investigational Medicinal Product (IMP) or excipients;

• Concurrent enrolment in another Investigational Medicinal Product trial;

• Severe hepatic impairment;

• Women who are currently pregnant or planning pregnancy or lactating

• Patient on anti-coagulants

• History of bleeding disorders