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Completed

NCT Number: NCT01311180

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

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asha Hospital, Hyderabad, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensoril®

Drug

Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks

Other names: Ashwagandha, Withania somnifera

Placebo

Drug

Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Natreon, Inc.

Industry

Registry information

Official study title

A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients With Generalized Anxiety Disorder.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2011
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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