Tenoten® in the Treatment of Somatoform, Stress-related and Other Neurotic Disorders

NCT03036293 | Completed Phase 4 Results

• 1 other identifier: MMH-TN-001
• Study Type: interventional
• Target: 390
• Locations: 2 countries
• Sites: 22

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Mean HAM-A Score at 12 Weeks of Treatment: 1. Group 1 (Tenoten®, 4 Tablets a Day); 2. Group 3 (Tenoten®, 8 Tablets a Day).

  The Hamilton Anxiety Rating Scale (HAM-A). Personality questionnaire designed to identify constitutive anxiety and situational anxiety. The scale consists of 14 items and measures both psychic anxiety and somatic anxiety. Total score is in range 0-56. Includes the symptoms of anxious mood, phobic, emotional, sleep disorders, depressive mood, somatic symptoms - muscular (pain, convulsions, etc.), sensory (e.g. tinnitus), cardiovascular, respiratory, gastrointestinal, genitourinary, neurovegetative. Major role belongs to behaviour during this interview. Anxiety scoring: ≤13 - no anxiety; 14-17 - mild anxiety disorder; 18-24 - moderate anxiety disorder; ≥25 - severe anxiety. Higher values represent a worse outcome

  12 weeks

Secondary Outcomes (6)

• Change From Baseline in the Mean HAM-A Score at 4 Weeks of Treatment: 1.1. Group 1 (Tenoten®, 4 Tablets a Day); 1.2. Group 3 (Tenoten®, 8 Tablets a Day).

  4 weeks

• The Mean HAM-A Score at 8 Weeks of Treatment: 2.1. Group 1 (Tenoten®, 4 Tablets a Day); 2.2. Group 3 (Tenoten®, 8 Tablets a Day).

  8 weeks

• Percentage of Patients Had at Least a 50% Improvement in the HAM-A Score: 3.1. Group 1 (Tenoten® 4 Tablets a Day): After 4, 8 and 12 Weeks; 3.2. Group 3 (Tenoten® 8 Tablets a Day): After 4, 8 and 12 Weeks.

  4,8,12 weeks

• Percentage of Patients With no Anxiety (HAM-A Score <14) in: 4.1. Group 1 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks; 4.3. Group 3 (Tenoten®, 4 Tablets a Day); After 4, 8 and 12 Weeks.

  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).

  12 weeks

Study Arms (4)

Tenoten, 2 tablets twice daily (4 tablets/day)

EXPERIMENTAL

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.

Drug: Tenoten

Placebo, 2 tablets twice daily (4 tablets/day)

PLACEBO COMPARATOR

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets twice daily (4 tablets/day). The tablets should be held in the mouth until dissolution, without meal.

Drug: Placebo

Tenoten, 2 tablets 4 times daily (8 tablets/day)

EXPERIMENTAL

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.

Drug: Tenoten

Placebo, 2 tablets 4 times daily (8 tablets/day)

PLACEBO COMPARATOR

Tablet for oral use. Dose per administration: 2 tablets. 2 tablets 4 times daily (8 tablets/days). The tablets should be held in the mouth until dissolution, without meal.

Drug: Placebo

Interventions

Tenoten DRUG

Tablet for oral use.

Tenoten, 2 tablets 4 times daily (8 tablets/day); Tenoten, 2 tablets twice daily (4 tablets/day)

Placebo DRUG

Tablet for oral use.

Placebo, 2 tablets 4 times daily (8 tablets/day); Placebo, 2 tablets twice daily (4 tablets/day)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes aged 18-45 years (inclusive).
• Patients diagnosed with somatoform, stress-related, and other neurotic disorders (F43, F45, and F48), in accordance with the ICD-10 criteria.
• A moderate and severe anxiety (HADS score ≥ 11) documented at screening.
• Patients providing signed Informed Consent form for participation in the clinical trial.
• Patients of reproductive age (of both sexes) using contraceptives and contraceptive methods during the study and for 30 days after the end of participation in the trial.

You may not qualify if:

• Moderate and severe depression symptoms recorded at screening (HADS score ≥ 11).
• Organic, including symptomatic, mental disorders (F00-09).
• Mental and behavioural disorders due to psychoactive substance use (F10-19).
• Schizophrenia, schizotypal and delusional disorders (F20-29).
• Mood \[affective\] disorders(F30-39).
• Phobic (F40) and other anxiety disorders (F41), obsessive-compulsive disorder (F42), dissociative \[conversion\] disorders (F44), depersonalization-derealization syndrome (F48.1).
• Behavioral syndromes associated with physiological disturbances and physical factors (F50-59).
• Disorders of adult personality and behavior (F60-69).
• Intellectual disabilities (F70-79).
• Inflammatory and traumatic brain injuries with permanent neurological deficit.
• Prior diagnosis of a class III or IV cardiovascular disease (according to the New York Heart Association, 1964)
• Malignant neoplasms/suspected malignant neoplasms.
• An allergy/intolerance to any of the components of medications used in the treatment.
• Malabsorption syndrome (including hereditary or acquired lactase or other disaccharidase deficiency) and galactosemia.
• Any conditions that, from investigator's point of view, may affect the patient's ability to participate in the trial.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (22)

Kazakh National Medical University named after S.D. Asfendiyarov

Almaty, 050000, Kazakhstan

Location

South - Kazakhstan State Pharmaceutical Academy

Shymkent, 160019, Kazakhstan

Location

Municipal Autonomous Healthcare Institution Order of the Red Banner of Labor City Clinical Hospital No. 1

Chelyabinsk, 454048, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Kazan Medical University" of the Ministry of Healthcare of the Russian Federation

Kazan', 420012, Russia

Location

The State Autonomic Health Care institution "Interregional clinical and diagnostical center"

Kazan', 420101, Russia

Location

LLC "City Center for Neurology and Pain Management"

Kazan', 420110, Russia

Location

Limited Liability Company "Family policlinic no. 4"

Korolyov, 141060, Russia

Location

State Budget Health Care institution of Moscow the City "Scientific and practical psychoneurological center n.a. Z.P. Solovyov" of the Administration of Health Care of Moscow City

Moscow, 115419, Russia

Location

The State Budget Health Care institution of Moscow the City "City clinical hospital No. 12 of the Administration of Health Care of Moscow City"

Moscow, 115516, Russia

Location

Pirogov Russian National Research Medical University

Moscow, 117997, Russia

Location

The State Budget Educational institution of High Professional Training I.M. Sechenov First Moscow State Medical University of Ministry of Health Care of the Russian Federation, Hospital of nervous diseases A.Y. Kozhevnikov

Moscow, 119992, Russia

Location

State budgetary institution of public health services of the Nizhniy Novgorod region "Nizhegorod Regional Clinical Hospital named after NA Semashko"

Nizhny Novgorod, 603126, Russia

Location

LLC "City Neurological Center" Sibneyromed "

Novosibirsk, 630064, Russia

Location

Pavlov First Saint Petersburg State Medical University/Department of Neurology and Manual Medicine

Saint Petersburg, 197022, Russia

Location

Pavlov First Saint Petersburg State Medical University/Department of Neurology with Clinic

Saint Petersburg, 197022, Russia

Location

State-Funded Healthcare Institution of the Samara Region "Samara City N.I. Pirogov Clinical Hospital №1"

Samara, 443096, Russia

Location

Saratov State Medical University named after V. I. Razumovsky

Saratov, 410012, Russia

Location

The State Budget Educational institution of High Professional Training Smolensk State Medical University of Ministry of Health Care of the Russian Federation, Smolensk regional clinical hospital

Smolensk, 214018, Russia

Location

The state budgetary health care institution of the Vladimir region "Regional Clinical Hospital"

Vladimir, 600023, Russia

Location

Volgograd State Medical University

Volgograd, 400131, Russia

Location

State Institution of Health of the Yaroslavl Region Clinical Hospital No. 8

Yaroslavl, 150030, Russia

Location

The State Health Care Institution Yaroslavl region "Clinical Hospital №8

Yaroslavl, 150030, Russia

Location

Related Publications (1)

• Parfenov VA, Kamchatnov PR, Khasanova DR, Bogdanov EI, Lokshtanova TM, Amelin AV, Maslova NN, Pizova NV, Belskaya GN, Barantsevich ER, Duchshanova GA, Kamenova SU, Kolokolov OV, Glazunov AB. The randomized clinical trial results of the anxiety treatment in patients with somatoform dysfunction and neurotic disorders. Sci Rep. 2021 Dec 20;11(1):24282. doi: 10.1038/s41598-021-03727-5.

  PMID: 34930979 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

tenoten

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Mikhail Putilovskiy, MD, PhD, Clinical and Medical Department Director
• Organization: Materia Medica Holding

PutilovskiyMA@materiamedica.ru

+74952761571

Study Officials

• Vladimir Parfenov, DrMedSci

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: February 8, 2017
• Primary Completion: September 22, 2018
• Study Completion: September 22, 2018
• Last Updated: December 31, 2020
• Results First Posted: December 31, 2020

Record last verified: 2019-08

Locations

KA (2); RU (20)