Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT02347033
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02347033
Study Brief:
Protocol Section:
NCT02347033