А Dose-finding Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder

NCT04524975 | Completed Phase 2

• 1 other identifier: CNS-CD0080045-04
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 15

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.

Conditions

Anxiety Disorder Generalized

Keywords

Anti-Anxiety Agents; Anxiety Disorder Generalized

Outcome Measures

Primary Outcomes (1)

• Frequency of treatment response

  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 \[% of patients\]

  Baseline to Week 8

Secondary Outcomes (13)

• Change of the HARS total score

  Baseline to Week 8, Week 8 to Week 9

• Change in the score sum of the mental and somatic anxiety subscales of HARS

  Baseline to Week 8

• Change of scores in items 1 (Anxious mood) and 2 (Tension) of HARS

  Baseline to Week 8

• Change of the sum of Hamilton Depression Rating Scale (HAM-D) scores

  Baseline to Week 8, Week 8 to Week 9

• Change in the Clinical Global Impression - Severity Scale (CGI-S)

  Baseline to Week 8, Week 8 to Week 9

Study Arms (3)

CD-008-0045 60 mg/day

EXPERIMENTAL

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

Drug: CD-008-0045

CD-008-0045 40 mg/day

EXPERIMENTAL

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.

Drug: CD-008-0045; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Patients assigned to the Placebo group will receive 1 placebo capsule before breakfast, lunch, and dinner for 8 weeks.

Drug: Placebo

Interventions

CD-008-0045 DRUG

CD-008-0045 20 mg capsules

CD-008-0045 40 mg/day; CD-008-0045 60 mg/day

Placebo DRUG

Placebo capsules

CD-008-0045 40 mg/day; Placebo

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent Form;
• Age 18 years and older;
• Generalized anxiety disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria and International Classification of Diseases (ICD-10);
• Hamilton Anxiety Rating Scale (HARS) values at Screening and on Randomization Visit (Week 0): Total score ≥ 20; Item 1 (Anxious mood) and Item 2 (Tension) scores ≥ 2;
• The CGI-S score ≥ 4 (moderate severity and higher) at Screening and on Randomization visit (Week 0);
• Consent of patients to use adequate contraception methods throughout the study. Adequate contraception methods include:
• Condoms with spermicide for males;
• For females (at their discretion):
• oral contraceptives
• condoms with spermicide (for the partner)
• diaphragm with spermicide
• cervical cap with spermicide
• intrauterine device
• Ability to comply with all Study Protocol requirements.

You may not qualify if:

• Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of childbearing potential (including those without history of surgical sterilization and women with \<2 years of post-menopause) not using adequate contraception methods;
• Item 1 (Depressed mood) of the Hamilton Depression Rating Scale (HAMD) score ≥ 2;
• Hamilton Depression Rating Scale (HAMD) total score \> 13;
• Confirmed diagnosis of depressive episode, recurrent depressive disorder, bipolar affective disorder in history or at Screening;
• Confirmed diagnosis of schizophrenia in history or at Screening;
• Confirmed diagnosis of panic disorder in history or at Screening;
• Phobic anxiety disorders (agoraphobia, social phobia, unspecified phobic anxiety disorder) in history or at Screening;
• Disorders of personality or behavior in history or at Screening;
• Post-traumatic stress disorder diagnosed within 12 months prior to Screening;
• Eating disorders diagnosed within 12 months prior to Screening;
• Somatoform disorders in history or at Screening;
• Obsessive-compulsive disorder in history or at Screening;
• Epilepsy, seizures, head trauma with loss of consciousness, tumors, inflammatory, or demyelinating diseases of the central nervous system, stroke in history;
• Pheochromocytoma;
• Malignancies diagnosed within the last 5 years (except for the cured basal cell carcinoma);

Sponsors & Collaborators

• ChemRar Research and Development Institute, LLC: lead

Study Sites (15)

Clinical Center LLC "Center for Psychotherapy "Support"

Stavropol, Stavropol Kray, Russia

Location

"Research Center for Mental Health" Scientific Institution

Moscow, Russia

Location

Clinical Center LLC "University Headache Clinic"

Moscow, Russia

Location

Moscow Research Institute of Psychiatry "National Medical Research Center for Psychiatry and Narcology named after V.P. Serbsky"

Moscow, Russia

Location

Nizhny Novgorod Clinical Psychiatric Hospital No.1

Nizhny Novgorod, Russia

Location

Clinical Center LLC "TREATMENT AND REHABILITATION RESEARCH CENTER "PHOENIX "

Rostov-on-Don, Russia

Location

Ryazan Medical University, Department of Psychiatry

Ryazan, Russia

Location

Clinical Center LLC "Doctor SAN"

Saint Petersburg, Russia

Location

Clinical Center LLC "Dynasty"

Saint Petersburg, Russia

Location

Leningrad Regional Psychoneurological Dispensary

Saint Petersburg, Russia

Location

St. Petersburg "Psychoneurological dispensary #5"

Saint Petersburg, Russia

Location

Clinical Center LLC "LION-MED"

Voronezh, Russia

Location

Clinical Center LLC "Medical practice"

Voronezh, Russia

Location

Yaroslavl Regional Psychiatric Hospital

Yaroslavl, Russia

Location

Clinical Center JSC "Medical Technologies"

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Margarita A Morozova, MD,PhD,Prof

  "Research Center for Mental Health" Scientific Institution

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Dose blinding will be performed using Placebo. Patient will receive 3 vials labeled for study drug administration as follows: 1 capsule in the morning, afternoon, and evening. Package numbers were assigned via IWRS. Thus, during the Study Treatment period, neither the patient nor the Investigator knew the group to which the patient was allocated. Single blinding was performed during the Placebo Run-in and Follow-up periods.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging pilot study to assess the efficacy and safety of CD-008-0045 in patients with GAD. The primary study objective is to select the dosage regimen for CD-008-0045 (20 mg BID or TID) based on preliminary assessment of its efficacy versus placebo according to frequency of treatment response at Week 8 in patients with GAD. Treatment response is considered as ≥ 50% decrease of the Hamilton Anxiety Rating Scale (HARS) total score from baseline.

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 24, 2020
• Study Start: October 2, 2018
• Primary Completion: August 20, 2019
• Study Completion: November 1, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (15)