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

NCT01311180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-04-21

No results posted yet for this study

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.

Conditions

  • Generalized Anxiety Disorder

Interventions

DRUG

Sensoril®

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Natreon, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • India

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01311180 on ClinicalTrials.gov