Clinical Trial Details

NCT ID: NCT00662259
Date Last Changed: May 21, 2009


Research Study Summary

Patients are needed to participate in a clinical research study evaluating Alprazolam (Xanax) and Placebo for the treatment of Generalized Anxiety Disorder

Research Study Title

Randomized, Double-Blind, Placebo-Controlled Study of a Benzodiazepine vs Placebo on Functional Magnetic Resonance Imaging (fMRI) of the Brain, and on Behavioral/Clinical Measures in Patients With Generalized Anxiety Disorder


The purpose of this study is to find out how an anti-anxiety drug or placebo affects the activity of your brain when you are at rest and when you are viewing emotional material, such as, emotional faces and pictures.

To Learn more

Recruitment Details

Both Male and Female
18 to 65 Years
Overall Status
Lead Sponsor
University of California, San Diego
20 Months
Facility Type


Both Male and Female ages 18 Years to 65 Years

Inclusion Criteria:

  1. Male or female between 18 - 65 years of age, inclusive

  2. In good general health (as determined by medical history, physical examination, laboratory assessments and ECG), especially no findings (including concomitant medications) that would constitute contraindications for treatment with alprazolam

  3. DSM-IV criteria for GAD (exception: at least 3 months of symptoms)

  4. HAM-A at screening > /= 20

  5. MADRS at screening < 25

  6. Prior medications washout:

  7. 2-week medication washout prior to randomization for most psychotropic medications

  8. If prior history of fluoxetine use, this drug must have been discontinued at least 5 weeks before randomization

  9. For females of non-childbearing potential: either postmenopausal for the past year (confirmed by an FSH level greater than 40 mIU/mL unless the subject is receiving HRT), or surgically sterile (e.g., tubal ligation, hysterectomy)

  10. Males and female subjects of child-bearing potential may be included if using appropriate contraceptive methods:

  11. must use abstinence or two methods of contraception throughout the trial:

  12. should include one primary (e.g., systemic hormonal contraception, vasectomy of the male partner) AND one secondary barrier method (e.g., latex condoms, spermicide) OR

  13. a double barrier method (e.g., latex condom plus spermicide (foam, suppository, gel, cream)) may be used

  14. GAD should be the clinically predominant disorder, as judged by the investigator, considering relative severity and impact on functioning

Exclusion Criteria:

  1. Axis I disorder other than stated above with the exception of the following permitted comorbidities:

  2. history of (within past 6 months) or current dysthymia

  3. current (within past 6 months) depressive episode with MADRS at baseline < 25

  4. history of major depression as long as no current depressive episode as defined above

  5. Drug or alcohol dependence in the past 6 months

  6. Positive urine toxicology (drugs of abuse as determined by clinician's assessment of positive urine test)

  7. Active suicidal ideation (determined by clinician)

  8. For females of childbearing potential: Pregnancy or intent to become pregnant or currently breastfeeding

  9. 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])

  10. Current regular use of antihistamines (except for inhalants which are permitted)

  11. Current use of herbal medication for mood or anxiety disorders and unwillingness to discontinue use for the duration of the study

  12. Current use of fluoxetine

  13. Concomitant psychotropic medications including regular use of sleeping medications (also herbals)

  14. 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

  15. Past intolerance (including allergic) to, or clear history of non-response to the study medication

  16. Current smoker ( > 10 cigarettes/day); habitual caffeine consumption of more than 400 mg/d (approximately 4 cups of coffee or equivalent)

  17. BMI > 32.5 kg/m2

  18. Contraindication to magnetic resonance imaging based on a standard fMRI screening forms

  19. Concurrent participation in an IRB approved investigational drug trial

  20. 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®)

Site Locations (1)

Country State City Zip Facility and Contact
United States California San Diego 92093 University of California, San Diego
Christina Wierenga, PhD

Gregory Brown, PhD


Elena Kosheleva

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