Case Study #5 – Palatability Study of Taste Test for Dog Chew

Palatability

For many preparations provided orally, palatability is a crucial factor. Bad testing dietary supplements – for humans and animals – would not be re-purchased by the customers. Pets’ taste is very sensitive and special attention should be paid to provide them with a tasty treat.

We have developed a formula based on relatively high doses of CBD and Gln – both are not a natural favorite for pets. However, ALL dogs who participated in the clinical trial loved the treats and were happy to eat it with the beneficial ingredients inside.

STUDY DESIGN

Pre-clinical - CBD Hemp Oil for Treatment of Depression - Study design:

Female BALB/c mice have been studied as a model for depression with and without cannabidiol (CBD), Hemp oil, imipramine, or vehicle administration, and depressive behavior has been assessed by their performance in the open Field Test, Tail Suspension Test, Forced Swim Test and Saccharin preference tests- validated tests for evaluation of depression and the neurological score (NSS) test. Blood was analyzed for biochemistry. Conclusions showed an anti-depressive and pro hedonic effect on the BALB/c mice at 5mg/kg and no toxicity. These findings extend the limited knowledge on the antidepressant effect of Hemp oil CBD, at a much lower concentration than CBD. These results suggest that Hemp Oil CBD may be beneficial for the treatment of clinical depression and postpartum depression [9]and other states with prominent anhedonia.

Clinical trial - CBD Hemp Oil for Treatment of Depression - Study design:

Cannabinoid derivatives, and in particular cannabidiol (CBD), have been drawing increased attention as potential therapeutic agents in a broad range of medical conditions, including mental disorders. Unlike delta-9-Tetrahydrocannabinol (THC), CBD does not cause psychotomimetic or cognitive untoward effects in humans. Still, evidence based clinical data regarding its potential beneficial and deleterious effects in psychiatry are scarce.

In our proposed add-on, placebo controlled double blind human clinical study we intended to assess the conceivable effect of CBD in major depression.

Several animal studies demonstrated the safety and efficacy of CBD, including for the treatment of depression and antidepressant-like effects of cannabidiol in mice with possible involvement of 5-HT1A receptor.

In our proposed human clinical trial, study population will comprise about 40 subjects, divided into two groups, a "study" group and a "placebo" group. All participants will initially undergo a detailed screening visit that will include a psychodiagnostic assessment confirming the diagnosis of a major depressive episode (MDE). Once this has been established, participants will undergo extensive observer-rated and self-report psychometric evaluation.

Study is designed as a prospective, add-on, placebo controlled, double blind study. All participants will be treated with antidepressant medication (ADM) as per conventional current standard of care. Choice and dosage of ADM will be individually tailored. Administration of the novel prepratation/Placebo will be randomized and double blind and will commence in conjunct with initiation of ADM treatment. Both, novel preparation and placebo will be similar in appearance, composition and taste.

Two rating systems will be employed – Observer rated and self-rated.