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A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01311180
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Natreon, Inc.

Tracking Information
First Submitted Date  ICMJE March 2, 2011
First Posted Date  ICMJE March 9, 2011
Last Update Posted Date April 21, 2015
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2011)
Change in the Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: 8 weeks ]
Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in HAM-A Total Score.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2011)
  • Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 8 weeks ]
    Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in MADRS Total Score
  • Change in the Clinical Global Impression Scales (CGI) for Severity scores. [ Time Frame: 8 weeks ]
    Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in CGI-Severity Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder
Official Title  ICMJE A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients With Generalized Anxiety Disorder.
Brief Summary

Sensoril - Extracts of Withania somnifera (Ashwagandha in Ayurvedic Medicine) have shown potent anti-stress, cortisol lowering, GABAergic, serotonergic and antioxidant properties in animal and human studies. Furthermore, controlled, single site human studies have shown the anxiolytic potential of WS extracts.The present study is a Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients with Generalized Anxiety Disorder. The primary objectives of this study are to assess the efficacy and safety of Sensoril® for patients with moderate or greater severity of symptoms associated with Generalized Anxiety Disorder.

The Primary Efficacy endpoint in this study will be determined by a statistically significantly greater improvement from baseline to endpoint in total Hamilton Anxiety Scale scores in the Sensoril® treated group versus those receiving placebo.

The secondary endpoints in this study will assess if Sensoril® treatment rather than placebo results in:

  1. Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last value)
  2. Greater remission rates (HAM-A total scores ≤ 7) at week 8
  3. Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety cluster scores.
  4. Greater improvements on CGI - severity scores from baseline to last value.
  5. A higher percentage of subjects rated as "much improved" or "very much improved" on the CGI - Improvement subscale at the last value.
  6. Serum cortisol and DHEA-S levels will be assessed between the two treatment groups. These biomarkers are indices of stress and it is hypothesized that improvement in levels of these stress indices will favor the Sensoril® treated group.

Exploratory Endpoint

1. Patient reported outcomes for sleep and calmness will be assessed between the two treatments.

Safety Endpoint

The safety endpoints will be determined by assessments of adverse and serious adverse events, physical examination, vital signs, EKG, and clinical laboratory measures. Clinical measures with laboratory defined reference ranges and vital signs will be assessed.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: Sensoril®
    Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
    Other Names:
    • Ashwagandha
    • Withania somnifera
  • Drug: Placebo
    Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
Study Arms  ICMJE
  • Experimental: Sensoril®
    Intervention: Drug: Sensoril®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01311180
Other Study ID Numbers  ICMJE Natreon-GAD-02-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Natreon, Inc.
Original Responsible Party Dr. Ratan Chaudhuri, Natreon, Inc.
Current Study Sponsor  ICMJE Natreon, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Natreon, Inc.
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP