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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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.
- •9. Patient’s biochemistry tests and medical tests are to be within normal ranges.
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)
- •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.
研究者
相似试验
已完成
3 期
A prospective, randomised, double-blind, multicentre, phase III clinical study on transarterial chemoembolisation (TACE) combined with sorafenib versus TACE plus placebo in patients with hepatocellular cancer (HCC) before liver transplantation (LTx) -Heidelberg Liver Cancer Study (HeiLivCa Study)CancerISRCTN24081794niversity of Heidelberg (Germany)204
进行中（未招募）
1 期
Phase III Trail of TACE + Sorafenib vs. TACE + Placebo for HCC Patients before Liver TransplantatioEUCTR2008-002269-29-DEniversitätsklinikum Heidelberg192
进行中（未招募）
1 期
A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.Chronic thromboembolic pulmonary hypertensionMedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2019-004131-24-FRACTELION Pharmaceuticals Ltd.230
暂停
3 期
A study to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertensioJPRN-jRCT2051200150akano Masayoshi144
进行中（未招募）
1 期
A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.EUCTR2019-004131-24-HUACTELION Pharmaceuticals Ltd.230