А Dose-finding Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder
- Registration Number
- NCT04524975
- Lead Sponsor
- ChemRar Research and Development Institute, LLC
- Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding pilot study to assess the efficacy and safety of CD-008-0045 in patients with Generalized Anxiety Disorder (GAD). Each patient will participate in the study for the period of approximately 10 weeks: Screening and Run-in period: 1 week; Study Treatment period: 8 weeks; Follow-up period: 1 week.
- Detailed Description
The study drug CD-008-0045 has a multi-targeted activity, i.e., able to inhibit adrenergic, dopamine, serotonin, and histamine receptors, thus allowing to assume its wide therapeutic potential. At Screening, the patients who meet the inclusion/exclusion criteria will be included into one-week single-blind Placebo Run-in period. At Week 0 the patients will be randomized to receive CD-008-0045 60 mg daily, CD-008-0045 40 mg daily or Placebo for 8 weeks. The potential withdrawal syndrome will be assessed during one-week Follow-up Period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD-008-0045 60 mg/day CD-008-0045 Patients assigned to the CD-008-0045 60 mg/day group will receive 1 capsule of CD-008-0045 (20 mg) before breakfast, lunch, and dinner for 8 weeks CD-008-0045 40 mg/day Placebo Patients assigned to the CD-008-0045 40 mg/day group will receive 1 capsule of CD-008-0045 (20 mg) before breakfast and before dinner, and 1 placebo capsule before lunch for 8 weeks. Placebo Placebo Patients assigned to the Placebo group will receive 1 placebo capsule before breakfast, lunch, and dinner for 8 weeks. CD-008-0045 40 mg/day CD-008-0045 Patients assigned to the CD-008-0045 40 mg/day group will receive 1 capsule of CD-008-0045 (20 mg) before breakfast and before dinner, and 1 placebo capsule before lunch for 8 weeks.
- Primary Outcome Measures
Name Time Method Frequency of treatment response Baseline to Week 8 Proportion of patients who demonstrate ≥ 50% decrease of the Hamilton Anxiety Rating Scale (HARS) \[the values from 0 to 56; the higher scores mean a worse outcome\] total score from baseline \[% of patients\]
- Secondary Outcome Measures
Name Time Method Change in the score sum of the mental and somatic anxiety subscales of HARS Baseline to Week 8 Mean change of the score sum of the mental and somatic anxiety subscales of the HARS score \[score\]
Change in the Clinical Global Impression - Severity Scale (CGI-S) Baseline to Week 8, Week 8 to Week 9 Mean change of CGI-S score \[the values from 1 to 7; the higher scores mean a worse outcome\] \[score\]
Clinical Global Impression - Improvement Scale (CGI-I) Week 4, Week 8, Week 9 Mean CGI-I score \[the values from 1 to 7; the higher scores mean a worse outcome\] \[score\]
Change of daytime somnolence level based on Visual Analogue Scale (VAS) Baseline to Week 8, Week 8 to Week 9 Mean change of VAS \[the values from 0 to 10; the higher scores mean a worse outcome\] score \[score\]
CD-008-0045 concentration prior to the next drug administration (Ctrough) Week 4, Week 8 Ctrough of CD-008-0045 \[ng/ml\]
M1 concentration prior to the next drug administration (Ctrough) Week 4, Week 8 Ctrough of M1 \[ng/ml\]
CD-008-0045 concentration 1 hour post drug administration (Cmax) Week 4, Week 8 Cmax of CD-008-0045 \[ng/ml\]
Change of the HARS total score Baseline to Week 8, Week 8 to Week 9 Mean change of HARS score \[score\]
Change of scores in items 1 (Anxious mood) and 2 (Tension) of HARS Baseline to Week 8 Mean change of the score in items 1 (Anxious mood) and 2 (Tension) of HARS \[score\]
Change of the sum of Hamilton Depression Rating Scale (HAM-D) scores Baseline to Week 8, Week 8 to Week 9 Mean change of HAM-D \[the values from 0 to 52; the higher scores mean a worse outcome\] score \[score\]
M1 concentration 1 hour post drug administration (Cmax) Week 4, Week 8 Cmax of M1 \[ng/ml\]
CYP2D6 polymorphism Week 4 CYP2D6 polymorphism \[type of metabolism\]
Incidence of adverse events (AE) and serious adverse events (SAE) Baseline to Week 9 Percent of patients with AEs and SAEs \[% of patients\]
Trial Locations
- Locations (15)
St. Petersburg "Psychoneurological dispensary #5"
🇷🇺Saint Petersburg, Russian Federation
"Research Center for Mental Health" Scientific Institution
🇷🇺Moscow, Russian Federation
Clinical Center LLC "Doctor SAN"
🇷🇺Saint Petersburg, Russian Federation
Nizhny Novgorod Clinical Psychiatric Hospital No.1
🇷🇺Nizhny Novgorod, Russian Federation
Clinical Center LLC "LION-MED"
🇷🇺Voronezh, Russian Federation
Clinical Center LLC "University Headache Clinic"
🇷🇺Moscow, Russian Federation
Clinical Center LLC "Dynasty"
🇷🇺Saint Petersburg, Russian Federation
Clinical Center LLC "Medical practice"
🇷🇺Voronezh, Russian Federation
Clinical Center LLC "Center for Psychotherapy "Support"
🇷🇺Stavropol, Stavropol Region, Russian Federation
Moscow Research Institute of Psychiatry "National Medical Research Center for Psychiatry and Narcology named after V.P. Serbsky"
🇷🇺Moscow, Russian Federation
Clinical Center LLC "TREATMENT AND REHABILITATION RESEARCH CENTER "PHOENIX "
🇷🇺Rostov-on-Don, Russian Federation
Ryazan Medical University, Department of Psychiatry
🇷🇺Ryazan, Russian Federation
Yaroslavl Regional Psychiatric Hospital
🇷🇺Yaroslavl, Russian Federation
Leningrad Regional Psychoneurological Dispensary
🇷🇺Saint Petersburg, Russian Federation
Clinical Center JSC "Medical Technologies"
🇷🇺Yekaterinburg, Russian Federation