VERITY THERAPEUTICS

CLINICAL TRIALS

Verity Therapeutics has conducted several unblinded, open label clinical trials with our products.  Working with the doctors and staff at the Florida Family Practice, our studies have investigated the efficacy of CBD for mild depression and acute pain.

Clinical Trial #1

Assessment of the Efficacy of Verity Therapeutics 750 mg Isolate CBD Spray Given Sublingually Twice Daily in the Treatment of Mild Depression using the Montgomery and Asberg Depression Rating Scale (MADRS)

G. Rosa, M.D. 

Florida Family Practice

Tampa, FL 

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Objective.  To assess the efficacy of Verity Therapeutics 750 mg isolate CBD medication given sublingually twice daily in the treatment of mild depression.

Method.  We conducted an open label trial of 7 patients suffering from mild depression as assessed using the Montgomery and Asberg Depression Rating Scale (MADRS) for a period of 30 days.  Patients were assessed on their initial visit using the MADRS rating scale and a baseline score was determined.  After 30 days of treatment, the study population was reassessed on the MADRS and a post treatment score was determined.  The MADRS was given both at the trial start and trial end by the same rater. All study participants were rated on all 10 MADRS questions and then an overall score was determined.

Results.  Seven patients were identified and completed the trial.  There was a 49% reduction in overall score on the MADRS which was a statistically significant outcome showing an overall improvement and reduction of depressive symptoms.  Other statistically significant outcomes were a 69% reduction in apparent sadness, a 50% reduction in inner tension, 53% reduction in reduced sleep representing an increase in normal sleep patterns and a 100% increase in reduced appetite representing a return to normal or increased appetite.  Also shown in this trial was a 29% reduction in reported sadness, a 56% reduction in lassitude (difficulty getting started of daily activities), 100% reduction in an inability to feel showing a normal interest in surroundings and people has returned.  Although numerically a reduction was shown, these changes did not reach statistical significance.  No conclusion could be reached due to the small sample size on effect in the area of pessimistic thoughts.  Suicidal thoughts could not be evaluated during this trial as none of the patients had suicidal ideation either at the beginning or end of the trial.

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Conclusion.  In the first trial of Verity Therapeutics 750 mg isolate spray given sublingually twice daily in the treatment of mild depression, a statistically significant improvement was seen in the overall MADRS score, apparent sadness, inner tension, sleep and appetite questions.  This trial also points to the need of a larger trial to be conducted to further evaluate efficacy in the areas of sadness, lassitude and an inability to feel as an improvement was seen numerically but these outcomes did not reach statistical significance.

Clinical Trial #2

Assessment of the Efficacy of Verity Therapeutics 500 mg Broad Spectrum Balm Applied Twice Daily for the Treatment of Acute Pain

G. Rosa, M.D. 

Florida Family Practice

Tampa, FL

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Objective.  To assess the efficacy of Verity Therapeutics 500 mg broad spectrum balm applied twice daily in the treatment of acute pain.

Method.  We conducted an open label trial of 7 patients suffering from acute pain localized to a single area.   Patients were given a pain diary and were instructed to assess their pain level twice a day for 7 days as a baseline.  On the 8th day patients were instructed to apply Verity Therapeutics 500 mg broad spectrum balm twice daily to the area that was experiencing acute discomfort.  Once active medication was started patients were instructed to wait one hour post dose to record their pain assessment on a scale of 0, no pain to 10, worst pain possible, twice daily.  Patients had to be on active treatment for a minimum of three weeks to be included in the trial results.  Six of the seven patients completed the full length of therapy. 

 

Results.  Six patients completed the trial.  Patients experienced an overall 57% reduction in their pain scores over the course of the trial.  This data was highly statistically significant.  The average pain score reported by patients was a 6 prior to treatment which was reduced to an average score of 2.6 one hour post treatment.  When looking at pain reduction after each of the dosing periods over 50% of the dosing periods experienced a great than 57% pain reduction, one of the dosing periods showed a 98% reduction in pain which represents almost a full resolution.

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Conclusion.  In the first trial of Verity Therapeutics 500 mg broad spectrum balm applied twice daily in the treatment of acute pain, trial results showed a 57% reduction in pain scores.  These data were statistically significant and show strong evidence to using Verity CBD broad spectrum balm for treatment of acute pain.