Enrolment Criteria |
Generalised Anxiety Disorder Group
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Inclusion Criteria |
Note that while the MINI 6.0 uses the DSM-IV criteria, the same criteria are used in the DSM-5. |
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Exclusion Criteria |
Primary diagnosis other than GAD
Presentation of moderate to severe depressive symptoms (MADRS ≥ 18) at the time of study entry
Presentation of suicidal ideation (≥ 3 on MADRS suicidal thoughts domain) at the time of study entry
Current diagnosis of a psychotic disorder (bipolar disorder I, schizophrenia) on structured interview (MINI 6.0)
Current or past diagnosis of obsessive compulsive disorder or bipolar I or II disorders
Current substance/alcohol use disorder on structured interview (MINI 6.0)
Currently taking an antidepressant, mood stabiliser, antipsychotic, anticonvulsant, warfarin, or thyroxin, or regularly using a benzodiazepine or opioid-based analgesic (more than 2 days per week)
Current use of St John’s wort
Three or more failed trials of pharmacotherapy for the current GAD episode
Recently commenced psychotherapy (within four weeks of study entry)
Known or suspected clinically unstable systemic medical disorder
Pregnant or breastfeeding or trying to conceive
Not using a medically approved form of contraception (including abstinence) if female and of childbearing age
Unable to participate in all scheduled visits, treatment plan, tests, and other trial procedures according to the protocol
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Imaging eligibility criteria—exclusions |
Left-handed
Pacemaker
Infusion pumps
Aneurysm clips
Metal prostheses
Metal joints
Metal rods
Metal plates
Metal staples
Non-removable body piercings
Persons who have worked as welders or may have metal splinters in their body
Females: taking hormone-modulating contraception including oral contraceptive pill or implants
Females: irregular menstrual cycle in order to ascertain days 1–10 for the conducting of scans
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