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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Natreon, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Natreon, Inc.
ClinicalTrials.gov Identifier:
NCT01311180
First received: March 2, 2011
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Drug: Sensoril®
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients With Generalized Anxiety Disorder.

Resource links provided by NLM:


Further study details as provided by Natreon, Inc.:

Primary Outcome Measures:
  • Change in the Hamilton Anxiety Rating Scale (HAM-A) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in HAM-A Total Score.


Secondary Outcome Measures:
  • Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in CGI-Severity Score


Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sensoril® 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
Placebo Comparator: Placebo Drug: Placebo
Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311180

Contacts
Contact: Rajeeb Khatua 408-512-1271 info@clinprax.com

Locations
India
Asha Hospital Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Prateep Mittapally    +91 4066752222    chytanyap@yahoo.com   
Principal Investigator: Gundugurti Prasad Rao         
Sheth V S General Hospital Recruiting
Ahmedabad, Gujurat, India, 380006
Contact: Girish Thakor       girish7188@yahoo.co.in   
Principal Investigator: Lakshman Dutt, MD         
Spandana Nursing Home Recruiting
Bangalore, Karnataka, India, 560010
Contact: Raghu Sivaraman    +91 80 23141027    raghusivaraman@hotmail.com   
Principal Investigator: Mahesh Gowda         
JSS Medical College Hospital Recruiting
Mysore, Karnataka, India, 570004
Contact: Sriram B Rao    +91 821 2442840    sriramabrao@gmail.com   
Principal Investigator: TSS Rao         
Sridhar Neuro Psychiatric Center Recruiting
Shimoga, Karnataka, India, 577204
Contact: Jamuna    +91 8182 274627    jamunaks@gmail.com   
Principal Investigator: K S Pavitra         
Poona Hospital & Research Centre Recruiting
Pune, Maharashtra, India, 411030
Contact: Priyanka Kamdar    +91 20 24327750    pkamdar@rediffmail.com   
Principal Investigator: Dhavale Madhav         
Manobal Medical Research Centre Recruiting
Lucknow, Uttar Pradesh, India, 226006
Contact: Maya Bajpai    +91 522 2651173    mayabajpai16@yahoo.co.in   
Principal Investigator: Jitendra K Trivedi         
Sponsors and Collaborators
Natreon, Inc.
  More Information

No publications provided

Responsible Party: Natreon, Inc.
ClinicalTrials.gov Identifier: NCT01311180     History of Changes
Other Study ID Numbers: Natreon-GAD-02-001
Study First Received: March 2, 2011
Last Updated: March 29, 2012
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014