Clinical Trial: Clinical Trial of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: International Multicenter, Double-blind, Randomized Parallel Group Placebo-controlled Clinical Trial of Efficacy and Safety of Different Dosing Regimens of Tenoten® in the Treatment of Anxiety in

Brief Summary:

The purposes of this study are:

  • To further examine the efficacy and safety of Tenoten® in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.
  • To compare the efficacy of two dosing regimens of Tenoten® (4 tablets daily vs.8 tablets daily, both for 12 weeks) in the treatment of anxiety in patients with somatoform, stress-related and other neurotic disorders.

Detailed Summary:
Sponsor: Materia Medica Holding

Current Primary Outcome: Change from baseline in the mean HAM-A score at 12 weeks of treatment in patients from: 1. Group 1 (Tenoten®, 4 tablets a day); 2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]

HAM-A


Original Primary Outcome: Change from baseline in the mean HAM-A score at 12 weeks of treatment in patients from: 1. Group 1 (Tenoten®, 4 tablets a day); 2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Change from baseline in the mean HAM-A score at 4 weeks of treatment in patients from: 1.1. Group 1 (Tenoten®, 4 tablets a day); 1.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 4 weeks ]
    HAM-A
  • The mean HAM-A score at 8 weeks of treatment versus baseline in patients from: 2.1. Group 1 (Tenoten®, 4 tablets a day); 2.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 8 weeks ]
    HAM-A
  • Percentage of patients achieving at least a 50% improvement in the HAM-A score from baseline in: 3.1. Group 1 (Tenoten®, 4 tablets a day) 3.1.1. at 4 weeks; 3.1.2. at 8 weeks; 3.1.3. at 12 weeks; 3.2. Group 3 (Tenoten®, 8 tablets a day) 3.2.1. at [ Time Frame: 4,8,12 weeks ]
    HAM-A
  • Percentage of patients with no anxiety (HAM-A score <14) in: 4.1. Group 1 (Tenoten®, 4 tablets a day) 4.1.1. at 4 weeks; 4.1.2. at 8 weeks; 4.1.3. at 12 weeks; [ Time Frame: 4,8,12 weeks ]
    HAM-A
  • Change from baseline in the total EQ-5D-3L score at 12 weeks of treatment in patients from: 5.1. Group 1 (Tenoten®, 4 tablets a day); 5.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]
    EQ-5D-3L
  • Total CGI scores in patients from: 6.1. Group 1 (Tenoten®, 4 tablets a day); 6.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]
    CGI


Original Secondary Outcome:

  • Change from baseline in the mean HAM-A score at 4 weeks of treatment in patients from: 1.1. Group 1 (Tenoten®, 4 tablets a day); 1.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 4 weeks ]
  • The mean HAM-A score at 8 weeks of treatment versus baseline in patients from: 2.1. Group 1 (Tenoten®, 4 tablets a day); 2.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 8 weeks ]
  • Percentage of patients achieving at least a 50% improvement in the HAM-A score from baseline in: 3.1. Group 1 (Tenoten®, 4 tablets a day) 3.1.1. at 4 weeks; 3.1.2. at 8 weeks; 3.1.3. at 12 weeks; 3.2. Group 3 (Tenoten®, 8 tablets a day) 3.2.1. at [ Time Frame: 4,8,12 weeks ]
  • Percentage of patients with no anxiety (HAM-A score <14) in: 4.1. Group 1 (Tenoten®, 4 tablets a day) 4.1.1. at 4 weeks; 4.1.2. at 8 weeks; 4.1.3. at 12 weeks; [ Time Frame: 4,8,12 weeks ]
  • Change from baseline in the total EQ-5D-3L score at 12 weeks of treatment in patients from: 5.1. Group 1 (Tenoten®, 4 tablets a day); 5.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]
  • Total CGI scores in patients from: 6.1. Group 1 (Tenoten®, 4 tablets a day); 6.2. Group 3 (Tenoten®, 8 tablets a day). [ Time Frame: 12 weeks ]


Information By: Materia Medica Holding

Dates:
Date Received: January 26, 2017
Date Started: February 8, 2017
Date Completion: March 2018
Last Updated: April 13, 2017
Last Verified: April 2017