At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 390 enrolled
Drug / intervention
Tenoten +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age 18-45 years
- ✓Diagnosis of somatoform, stress-related, or neurotic disorders (F43, F45, F48 per ICD-10)
- ✓Moderate or severe anxiety with HADS score ≥11 at screening
Key exclusion· 17
- ✕Moderate or severe depression (HADS score ≥11)
- ✕Organic or symptomatic mental disorders (F00-09)
- ✕Psychoactive substance use disorders (F10-19)
- ✕Schizophrenia, schizotypal, or delusional disorders (F20-29)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
International Multicenter, Double-blind, Randomized Placebo-controlled Phase IV Clinical Trial of Different Dosing Regimens of Tenoten® in the Treatment of Anxiety in Patients With Somatoform, Stress-related and Other Neurotic Disorders
In Brief
A Phase 4 clinical trial evaluating Tenoten and Placebo for Anxiety. Completed, enrolled 390 participants across 22 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnxiety
CountriesKazakhstan, Russia
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartFeb 2017
Primary CompletionSep 2018
TodayJul 2026
First PostedJan 30, 2017
Enrollment StartFeb 8, 2017
Primary CompletionSep 22, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.4 years ago
Interventions
Tenotendrug
Tablet for oral use.
Placebodrug
Tablet for oral use.