Back to resultsA Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Sensoril®
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility 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.
Sites / Locations
- Asha Hospital
- Sheth V S General Hospital
- Spandana Nursing Home
- JSS Medical College Hospital
- Sridhar Neuro Psychiatric Center
- Poona Hospital & Research Centre
- Manobal Medical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sensoril®
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in the Hamilton Anxiety Rating Scale (HAM-A) total score
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
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.
Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in CGI-Severity Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01311180
Brief Title
A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder
Official Title
A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients With Generalized Anxiety Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Natreon, Inc.
4. Oversight
5. Study Description
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:
Greater response rates (≥ 50% improvement in HAM-A total scores from baseline to last value)
Greater remission rates (HAM-A total scores ≤ 7) at week 8
Greater improvement from baseline to week 8 in HAM -A psychic and somatic anxiety cluster scores.
Greater improvements on CGI - severity scores from baseline to last value.
A higher percentage of subjects rated as "much improved" or "very much improved" on the CGI - Improvement subscale at the last value.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensoril®
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sensoril®
Other Intervention Name(s)
Ashwagandha, Withania somnifera
Intervention Description
Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
Primary Outcome Measure Information:
Title
Change in the Hamilton Anxiety Rating Scale (HAM-A) total score
Description
Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in HAM-A Total Score.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Description
Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in MADRS Total Score
Time Frame
8 weeks
Title
Change in the Clinical Global Impression Scales (CGI) for Severity scores.
Description
Mean change from Visit 2 (Baseline) to Visit 7 or Early Termination Visit in CGI-Severity Score
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Asha Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
Sheth V S General Hospital
City
Ahmedabad
State/Province
Gujurat
ZIP/Postal Code
380006
Country
India
Facility Name
Spandana Nursing Home
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
Facility Name
JSS Medical College Hospital
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570004
Country
India
Facility Name
Sridhar Neuro Psychiatric Center
City
Shimoga
State/Province
Karnataka
ZIP/Postal Code
577204
Country
India
Facility Name
Poona Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411030
Country
India
Facility Name
Manobal Medical Research Centre
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226006
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder
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