Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Natreon, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult men and women between the ages of 18 and 65 years (who have completed their 18th birthday but have not completed their 66th birthday) with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR, APA, 2000) diagnosis of GAD - Generalized Anxiety Disorder.
Hamilton Anxiety Rating Scale (HAM-A) total score ≥ 20 at the screening and randomization visits.
HAM-A Item 1 (anxious mood) ≥ 2 at the screening and randomization visits.
HAM-A Item 2 (tension) ≥ 2 at the screening and randomization visits.
Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤ 12, with MADRS items #1 and #2 "apparent sadness" and "reported sadness" ≤ 2 at the screening and randomization visits.
Clinical Global Impression-Severity of Illness (CGI-S) score ≥ 4 at the screening and randomization visits.
Written Informed Consent present prior to conduct of any study related procedures
You may not be if
Any DSM-IV-TR Axis I disorder other than GAD within 6 months prior to the screening visit.
Any DSM-IV-TR Axis II disorder that is likely to interfere with the patient's ability to participate in the study.
Current serious suicidal or homicidal risk, MADRS Item 10 (suicidal thoughts) score \> 1, at the screening or randomization visit or a suicide attempt in the 6 months prior to screening.
Substance or alcohol dependence within 6 months prior to screening. (except Nicotine and/or caffeine)
Clinically significant deviation from the reference range in clinical laboratory test results during the screening phase and prior to randomization.
Women who test positive for pregnancy at the screening visit or women who are breast feeding at the screening visit.
Any thyroid laboratory measures that are considered clinically significant during the screening phase.
Current (or within past 2 months prior to screening) use of any extract of Withania Somnifera.
Any known allergy to Withania Somnifera extracts.
Current (or within the past 2 months prior to screening) over the counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3.
Specific Concomitant medicines (a table will specify "allowed" and "disallowed" medicines). \[Appendix 13\]
Currently (or within the past 2 months prior to screening) receiving any psychotropic medicines (e.g. Anti-anxiety drugs or anti-depressants, or anti-psychotic agents or mood stabilizers).
Currently (or within the past 2 months prior to screening) receiving any investigational drugs or medical devices.
Currently (or within the past 2 months prior to screening) undertaking psychotherapy for anxiety or depression.
Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study.
