A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

NCT05586789 | Completed Phase 3

• 1 other identifier: RAN-03-03-2022
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 10

Brief Summary

The primary objective of the study is to evaluate the efficacy of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo for the treatment of patients with anxiety in neurasthenia and adjustment disorder. An additional study objective was to evaluate the safety of Ranquilon, 1 mg tablets, at a dose of 6 mg/day compared to placebo in patients with anxiety in neurasthenia and adjustment disorder.

Conditions

Anxiety; Neurasthenia; Adjustment Disorders

Outcome Measures

Primary Outcomes (1)

• Change in patient status on the Hamilton Anxiety Rating Scale (HARS): Percentage of patients with a significant, i.e., 50% or greater reduction from baseline, in HARS anxiety levels on Day 29 ± 1

  HARS scale includes 14 items, each of which is rated on the Likken scale. Of these, 13 items relate to the manifestation of anxiety in daily life, 14 items relate to the manifestation of anxiety during examinations. The sum of the scores may range from 0 to 56, with scores 0 to 7 corresponding to the absence of anxiety, 8 to 17 to the presence of symptoms of anxiety disorder, 18 to 24 to moderate severity of anxiety disorder, and 25 to 56 to severe severity of anxiety disorder.

  Day 29 ± 1 of the study

Secondary Outcomes (60)

• Proportion of patients with a significant, i.e., 50% or greater reduction in HARS anxiety level on Day 15 ± 1 (Visit 2)

  Day 15 ± 1 of the study

• Change in HARS anxiety level on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3) compared to baseline

  Day 15 ± 1 and Day 29 ± 1 of the study

• Proportion of patients with HARS anxiety scores reduced to 17 or less on Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)

  Day 15 ± 1 and Day 29 ± 1 of the study

• Time to decrease the HARS anxiety level to a score of 17 or less

  Screening, Day 15 ± 1, Day 29 ± 1 of the study, the end of the study (Day 44 ± 1) or an early termination visit, whichever came first

• Proportion of patients with significant and marked improvement as assessed by the physician (Clinical Global Impression - improvement (CGI-i) score 1 or 2) at Day 15 ± 1 (Visit 2) and Day 29 ± 1 (Visit 3)

  Day 15 ± 1 and Day 29 ± 1 of the study

Study Arms (2)

Ranquilon

EXPERIMENTAL

Study drug Ranquilon, tablets, 1 mg, 2 tablets 3 times a day (daily dose - 6 mg/day), daily, for 28 days

Drug: Ranquilon

Placebo

PLACEBO COMPARATOR

Placebo, tablets, 2 tablets 3 times a day, daily, for 28 days

Drug: Placebo

Interventions

Ranquilon DRUG

Two 1 mg tablets 3 times per day for 28 days

Also known as: GB-115, 6-phenylhexanoyl)glycyl-L-tryptophan amide

Ranquilon

Placebo DRUG

Two tablets 3 times per day for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 70
• Presence of written consent to participate in the study in accordance with applicable law
• Patients with anxiety and diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2)
• HARS anxiety scores of 18-24
• Severity of asthenia on the Asthenia Self Assessment Scale (MFI-20) of more than 50 points
• Hamilton Depression Assessment Scale (HAMD-17) score \< 6
• CGI-s scale score of at least 4
• Negative pregnancy test for women of preserved reproductive potential
• Consent to use effective contraception for the duration of the study and 30 days after completion (for women of unresolved reproductive potential and men)
• Ability to understand the requirements for study participants, to give written consent to participate in the study (including the use and communication of patient health information relevant to the study) and to comply with the procedures of the study protocol

You may not qualify if:

• Known intolerance to the active ingredient and/or excipients in the study drug/placebo of the study drug
• Known presence of lactase deficiency, lactose intolerance, glucose-galactose malabsorption or galactose intolerance
• Patients who require concomitant therapy prohibited in this study (MAO inhibitors, antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), sleeping pills when used on a continuous basis), or have taken these drugs within the last month
• Established or suspected alcohol/drug use at the time of screening or randomization, and/or a history of alcohol, drug or drug dependence
• Presence of cancer, including a history of cancer (with the exception of a cured tumor with sustained remission for more than 5 years)
• Presence of tuberculosis, including a history of tuberculosis
• The presence of HIV, chronic viral hepatitis B/C, syphilis (including a history), or a positive test for HIV, hepatitis B/C, syphilis at screening
• Patients with a diagnosis established on the basis of ICD-10 criteria: other anxiety disorders (F41)
• Schizophrenia, schizoaffective, affective and panic disorders
• Acute psychosis (endogenous-procedural, organic or somatogenic), including history
• Organic lesions of the central nervous system of traumatic and alcoholic genesis
• Postencephalitic syndrome
• Brain tumors, including in the anamnesis
• Degenerative diseases of the central nervous system (CNS), in particular, multiple sclerosis
• Depression, including a history of depression

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (10)

Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region

Engel's, 413090, Russia

Location

State Budgetary Health Institution of Nizhny Novgorod Oblast "Clinical Psychiatric Hospital No. 1 of Nizhny Novgorod. Nizhny Novgorod"

Nizhny Novgorod, 603155, Russia

Location

Professors' Clinic LLC.

Perm, 614070, Russia

Location

Limited Liability Company "Research Center Eco-Security"

Saint Petersburg, 191119, Russia

Location

EosMED JSC

Saint Petersburg, 194000, Russia

Location

Limited Liability Company "Energy of Health"

Saint Petersburg, 194156, Russia

Location

LLC "Aurora MedFort"

Saint Petersburg, 194156, Russia

Location

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

Location

Limited Liability Company "Meili"

Saint Petersburg, 199406, Russia

Location

Saratov City Psychoneurological Dispensary

Saratov, 410038, Russia

Location

MeSH Terms

Conditions

Anxiety Disorders; Neurasthenia; Adjustment Disorders

Interventions

GB-115

Condition Hierarchy (Ancestors)

Mental Disorders; Somatoform Disorders; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: October 14, 2022
• First Posted: October 19, 2022
• Study Start: October 12, 2022
• Primary Completion: November 22, 2022
• Study Completion: January 3, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

RU (10)