A clinical (randomised controlled) trial comparing treatments for generalised anxiety disorder (GAD) with patients who have failed to respond to low intensity psychological interventions as defined by the NICE GAD guidelines: the drug Sertraline versus Cognitive Behavioural Therapy.

Phase 1

• Conditions: Generalised anxiety disorder (GAD); MedDRA version: 18.0 Level: PT Classification code 10018075 Term: Generalised anxiety disorder System Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2014-004077-16-GB
• Lead Sponsor: niversity College London Joint Research Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-01
• Study Completion: 2016-02-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Aged 18 or above
Gender: male or female
Positive score of 10+ on GAD-7
Primary diagnosis of GAD as diagnosed on the Mini-International Neuropsychiatric Interview (M.I.N.I.)
Failure to respond to NICE defined step 1 and 2 low intensity interventions for GAD
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

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
Concurrent enrolment in another IMP (medication) trial
Women who are currently pregnant or planning pregnancy or lactating
Severe hepatic impairment
Patient on anti-coagulants
History of a bleeding disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified