Generalized Anxiety DisorderPhase 2NCT01311180
A Clinical Trial to Study the Effects of Sensoril® for Patients With Generalized Anxiety Disorder
A Phase 2 study testing Sensoril® in people with Generalized Anxiety Disorder, run by Natreon, Inc. at 7 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Sensoril®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 7 sitesIndia
- Study dates
- Mar 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
Sheth V S General Hospital
Ahmedabad, Gujurat, 380006
Spandana Nursing Home
Bangalore, Karnataka, 560010
Asha Hospital
Hyderabad, Andhra Pradesh, 500034
Manobal Medical Research Centre
Lucknow, Uttar Pradesh, 226006
JSS Medical College Hospital
Mysore, Karnataka, 570004
Poona Hospital & Research Centre
Pune, Maharashtra, 411030
Sridhar Neuro Psychiatric Center
Shimoga, Karnataka, 577204
About this study
Official title: A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial 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.
Read more
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
- 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
- Being tested
- Sensoril®, Placebo
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensoril®Drug
Also called Ashwagandha, Withania somnifera
Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
PlaceboDrug
Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sensoril® | Experimental | Not described Receives: Drug: Sensoril® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natreon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311180
- Sponsor's protocol ID
- Natreon-GAD-02-001
- Status last verified
- Apr 2015
- First submitted
- 2 Mar 2011
- Last updated
- 21 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind, Parallel Group, Randomized, Placebo Controlled Clinical Trial of Sensoril® for Patients With Generalized Anxiety Disorder.
- ClinicalTrials.gov ID
- NCT01311180
- Acronym / sponsor ID
- Natreon-GAD-02-001
- Conditions
- Generalized Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Natreon, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensoril® | Experimental | Drug: Sensoril® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensoril®Also: Ashwagandha, Withania somniferaStart with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks | Drug | Sensoril® |
| PlaceboStart with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Change in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Time frame: 8 weeks
Change in the Clinical Global Impression Scales (CGI) for Severity scores.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
Related trials for Generalized Anxiety Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sensoril® in people with Generalized Anxiety Disorder, run by Natreon, Inc. at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Hamilton Anxiety Rating Scale (HAM-A) total score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.