Health Condition 1: null- Generalized Anxiety Disorder
Conditions
Interventions
Intervention1: Sensoril®: Start With 250 Mg P.o. QAM For 7
Days And Then 250 Mg P.o. Bid For 7
Weeks
Control Intervention1: Placebo: Start With 250 Mg Po QAM For 7 Days
And Then 250 Mg Po Bid For 7 We
Sponsors
Natreon Inc
Clinprax Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change In The HAMA Total ScoreTimepoint: From Visit 2 (Baseline) To Visit 7 (Week 8) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change In The MADRS Total Score And CGI-Severity Scores.Timepoint: From Visit 2 To Visit 7 Or ET | — |
Countries
India
Contacts
Public ContactDr Rajeeb Khatua
Clinprax Research Private Ltd.
Outcome results
None listed