Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder

Exclusion Criteria

• •1. Axis I disorder other than stated above with the exception of the following permitted comorbidities:
• •* history of (within past 6 months) or current dysthymia
• •* current (within past 6 months) depressive episode with MADRS at baseline \< 25
• •* history of major depression as long as no current depressive episode as defined above
• •2. Drug or alcohol dependence in the past 6 months
• •3. Positive urine toxicology (drugs of abuse as determined by clinician's assessment of positive urine test)
• •4. Active suicidal ideation (determined by clinician)
• •5. For females of childbearing potential: Pregnancy or intent to become pregnant or currently breastfeeding
• •6. Current use of beta-blockers or stimulants (e.g., Methylphenidate, d-Amphetamine, modafinil, and illicit drugs like cocaine or 3,4-methylenedioxy-N-methylamphetamine \[MDMA\])
• •7. Current regular use of antihistamines (except for inhalants which are permitted)
• •8. Current use of herbal medication for mood or anxiety disorders and unwillingness to discontinue use for the duration of the study
• •9. Current use of fluoxetine
• •10. Concomitant psychotropic medications including regular use of sleeping medications (also herbals)
• •* occasional use of sleeping medication, with the exception of benzodiazepines, is permitted as long as it is not taken the evening prior to a visit
• •11. Past intolerance (including allergic) to, or clear history of non-response to the study medication
• •12. Current smoker (\> 10 cigarettes/day); habitual caffeine consumption of more than 400 mg/d (approximately 4 cups of coffee or equivalent)
• •13. Body mass index \> 32.5 kg/m2
• •14. Contraindication to magnetic resonance imaging based on a standard fMRI screening forms
• •15. Concurrent participation in an institutional review board (IRB) approved investigational drug trial
• •16. Any other reason why, per clinician, the patient should not participate in this study (to be included in this assessment are all considerations, warnings, precautions as per current FDA-approved drug label for Xanax®)