Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Cannabidiol oral solution 150mg/ml: The estimated study duration will be approximately 15 weeks of duration.
Control Intervention1: Matching Placebo, oral solution: The estimated study
Sponsors
Leiutis Pharmaceuticals LLP
Leiutis Pharmaceuticals LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18-65 years’ male and female subjects. 2. Patients who understand the nature of the study and provide written informed consent. 3. ICD 11 criteria for ascertaining presence of generalized anxiety disorders. 4. Patients will be screened using Depression Anxiety Stress Scale-21 questionnaire (attached in to be used to determine if they are mild to moderate anxiety patients. 5. Subsequently, the screened patients will be evaluated using GAD-7, HAM-A, CGI-I, CGI-S, PHQ-9 and PSQI questionnaire to ascertain the anxiety score. Patients who have mild to moderate anxiety scores will be considered for the study. 6. Patients who are cooperative, reliable, and agree to comply with protocol procedures. 7. Female patients (non-pregnant and non-lactating with adequate protection from conception). Females of childbearing potential must agree to use an acceptable method of birth control (including barrier method contraceptives or intrauterine device). Women with history of bilateral tubal ligation, women who have undergone total hysterectomy or women who are two years’ post-menopausal are also eligible. 8. At the end of the placebo run in period, investigator will record the subject’s scores of GAD -7, HAM-A, CGI-I, CGI-S, PHQ-9, and PSQI. If there is any change from screening score greater than or equal to 25% from baseline at the end of placebo run in period, then the subject will not be randomized and excluded from the study. 9. Patient’s biochemistry tests and medical tests are to be within normal ranges.
Exclusion criteria
Exclusion criteria: 1. Comorbidity and evidence of clinically significant disease such as unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, hypertensive, immunological, or pulmonary diseases or ongoing malignancies. 2. Diagnosed with abnormalities of the thyroid hormone (TSH) will be excluded from the study. 3. Compromised respiratory function or severe respiratory insufficiency. 4. Clinically significant abnormal laboratory values within the past 14 days, including: Liver function tests (LFTs) such as albumin, direct bilirubin, total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT). 5. Patients will be excluded, if they met criteria for a recent (6 month) diagnosis of MDD or substance abuse/dependence; a past year history of panic disorder, post-traumatic stress disorder, or eating disorder; or a lifetime history of psychotic, bipolar, obsessive– compulsive disorder, or psychosis. Patients required to be free of psychotropic medications at least 4 weeks prior to randomization, any medical illness that would contraindicate the use of CBD; psychotherapy that was initiated within 6 weeks prior to enrollment; and the use of any concomitant medications that were excluded due to concerns about safety or psychotropic effects. 6. Lack of response of the GAD to prior trials of antidepressant or benzodiazepine treatments; any medical illness that would contraindicate the use of Cannabidiol. 7. A history of epilepsy or brain damage, cardiac, renal or liver abnormalities. 8. A history of allergies to Cannabidiol or related class of drugs. 9. Individuals taking certain medications known to have potential interactions with CBD (i.e., steroids, HMG-CoA reductase inhibitors, calcium channel blockers, antihistamines, antivirals,immune modulators, benzodiazepines, anti arrhythmic, antibiotics, anesthetics, antipsychotics, antidepressants, anti-epileptics, beta blockers, proton pump inhibitors, NSAIDs, angiotensin II blockers, oral hypoglycemic agents, and sulfonylureas) 10. Used cannabis, synthetic cannabinoid, cannabinoid analogue, or any CBD or THC-containing product will be excluded from the study. 11. Individuals that had been diagnosed with intestinal, liver, or renal diseases will be excluded from the study. 12. The presence of clinically significant laboratory findings in the opinion of the investigator including, but not limited to, clinically significant anemia or transaminase elevation. 13. Smoking, alcohol and drug abuse patients will be excluded from this study. 14. After assessment of the subject, subject inclusion will be in the opinion of investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The GAD-7 at the end of treatment Visit 9 (Week 11) as compared to baseline. The HAM-A at the end of treatment Visit 9 (Week 11) as compared to baseline.Timepoint: Baseline & Week-11 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the score CGI-I at the end of treatment as compared to baseline. Change in the score CGI-S at the end of treatment as compared to baseline. Change in the score PHQ-9: Patient´s Health Questionnaire-9, at the end of treatment as compared to baseline. Change in Pittsburgh Sleep Quality Index (PSQI) at end of treatment as compared to baseline. Plasma levels of CBD in subjects during treatment shall be monitored in patients recruited at 1 to 3 sites where in aliquot blood samples for PK analysis shall be collected from patients at visits 2, 3, 6, 7, 9, and 11.Timepoint: Baseline & Week-11 | — |
Countries
India
Contacts
Public ContactDr Laxman Kumar
Hinge Clinica Pvt. Ltd
Outcome results
None listed