CTRI/2023/01/049110
已完成
3 期
A prospective, randomised, double-blind, multicenter comparative study to Evaluate the Efficacy, Safety and Pharmacokinetics of Cannabidiol oral solution versus matching Placebo for treatment of mild to moderate anxiety disorders. - CP-CBD001-22
eiutis Pharmaceuticals LLP0 个研究点目标入组 178 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- eiutis Pharmaceuticals LLP
- 入组人数
- 178
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
未指定
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