Anxiety Disorder GeneralizedPhase 2NCT04524975
А Dose-finding Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder
A Phase 2 study testing CD-008-0045 in people with Anxiety Disorder Generalized, run by ChemRar Research and Development Institute, LLC at 15 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder Generalized
- What is being tested?
- CD-008-0045
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 15 sitesRussia
- Study dates
- 2 Oct 2018to 1 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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);
- Significant cardiovascular diseases diagnosed at present or within 12 months prior to Screening, including: Chronic heart failure, class III or IV (according to New York Heart Association classification); severe arrhythmia requiring treatment with class Ia, Ib, Ic, or III antiarrhythmic drugs; unstable angina; myocardial infarction; heart and coronary artery surgery; significant valvular heart disease; uncontrolled hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg; pulmonary embolism or deep vein thrombosis;
- Nephrotic syndrome; moderate to severe chronic renal failure or significant renal diseases with creatinine level >1.5 mg/dL (132 μM/L) in males and > 1.4 mg/dL (123 μM/L) in females, or glomerular filtration rate (GFR) < 60 mL/min;
- HIV, hepatitis B or C, liver cirrhosis in history; AST, ALT, or serum alkaline phosphatase ≥ 2.5 times above the upper limit of normal; total bilirubin level ≥ 2 times above the upper limit of normal at Screening;
- Significant dysfunctions of the thyroid gland in decompensation stage;
- Anemia (hemoglobin level ≤ 105 g/L in females or ≤ 115 g/L in males); significant blood loss, or collection of at least one volumetric unit of donated blood (≥ 500 ml), or blood transfusion within 12 weeks prior to Screening;
- Any uncontrolled concomitant somatic disease, including that with a stable treatment regimen;
- Drugs administered for generalized anxiety disorder, starting from Screening and throughout the study, including antidepressants, Pregabalin, benzodiazepines, antipsychotics;
- Fluoxetine use within 21 days prior to Screening and throughout the study;
- Known allergy, hypersensitivity or contraindications to CD-008-0045;
- Electroconvulsive therapy within 3 months prior to Screening;
- Psychotherapy within 3 months prior to Screening and/or at the time of enrollment into the study;
- Use of prohibited drug therapy from the moment of Screening and throughout the study;
- Administration of any study drug or participation in another clinical study within 3 months prior to Screening (except for cases when the patient was not administered the study drug during the study);
- Addiction to tranquilizers or psychoactive substance abuse, including alcohol (history of episodic use is acceptable);
- Inability to read or right; unwillingness to understand and comply with the Protocol procedures; non-compliance with drug dosage regimen or procedures which, in the Investigator's opinion, may affect the study results or the patient's safety and prevent the patient's participation in the study; any other concomitant diseases or severe mental disorders, which make the patient ineligible for participation in the study, limit the legal basis for Informed Consent procedure, or may affect the patient's ability to participate in the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
"Research Center for Mental Health" Scientific Institution
Moscow
Clinical Center LLC "University Headache Clinic"
Moscow
Moscow Research Institute of Psychiatry "National Medical Research Center for Psychiatry and Narcology named after V.P. Serbsky"
Moscow
Nizhny Novgorod Clinical Psychiatric Hospital No.1
Nizhny Novgorod
Clinical Center LLC "TREATMENT AND REHABILITATION RESEARCH CENTER "PHOENIX "
Rostov-on-Don
Ryazan Medical University, Department of Psychiatry
Ryazan
Clinical Center LLC "Doctor SAN"
Saint Petersburg
Clinical Center LLC "Dynasty"
Saint Petersburg
Leningrad Regional Psychoneurological Dispensary
Saint Petersburg
St. Petersburg "Psychoneurological dispensary #5"
Saint Petersburg
Clinical Center LLC "Center for Psychotherapy "Support"
Stavropol, Stavropol Kray
Clinical Center LLC "LION-MED"
Voronezh
Clinical Center LLC "Medical practice"
Voronezh
Yaroslavl Regional Psychiatric Hospital
Yaroslavl
Clinical Center JSC "Medical Technologies"
Yekaterinburg
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Anxiety Disorder Generalized
- Being tested
- CD-008-0045, Placebo
- Keywords
- Anti-Anxiety Agents, Anxiety Disorder Generalized
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD-008-0045Drug
CD-008-0045 20 mg capsules
PlaceboDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: Baseline to Week 8
Secondary outcomes (13)
Change of the HARS total score
Mean change of HARS score [score]
Measured: Baseline to Week 8, Week 8 to Week 9
Change in the score sum of the mental and somatic anxiety subscales of HARS
Mean change of the score sum of the mental and somatic anxiety subscales of the HARS score [score]
Measured: Baseline to Week 8
Change of scores in items 1 (Anxious mood) and 2 (Tension) of HARS
Mean change of the score in items 1 (Anxious mood) and 2 (Tension) of HARS [score]
Measured: Baseline to Week 8
Change of the sum of Hamilton Depression Rating Scale (HAM-D) scores
Mean change of HAM-D [the values from 0 to 52; the higher scores mean a worse outcome] score [score]
Measured: Baseline to Week 8, Week 8 to Week 9
Change in the Clinical Global Impression - Severity Scale (CGI-S)
Mean change of CGI-S score [the values from 1 to 7; the higher scores mean a worse outcome] [score]
Measured: Baseline to Week 8, Week 8 to Week 9
Clinical Global Impression - Improvement Scale (CGI-I)
Mean CGI-I score [the values from 1 to 7; the higher scores mean a worse outcome] [score]
Measured: Week 4, Week 8, Week 9
Change of daytime somnolence level based on Visual Analogue Scale (VAS)
Mean change of VAS [the values from 0 to 10; the higher scores mean a worse outcome] score [score]
Measured: Baseline to Week 8, Week 8 to Week 9
CD-008-0045 concentration prior to the next drug administration (Ctrough)
Ctrough of CD-008-0045 [ng/ml]
Measured: Week 4, Week 8
M1 concentration prior to the next drug administration (Ctrough)
Ctrough of M1 [ng/ml]
Measured: Week 4, Week 8
CD-008-0045 concentration 1 hour post drug administration (Cmax)
Cmax of CD-008-0045 [ng/ml]
Measured: Week 4, Week 8
M1 concentration 1 hour post drug administration (Cmax)
Cmax of M1 [ng/ml]
Measured: Week 4, Week 8
CYP2D6 polymorphism
CYP2D6 polymorphism [type of metabolism]
Measured: Week 4
Incidence of adverse events (AE) and serious adverse events (SAE)
Percent of patients with AEs and SAEs [% of patients]
Measured: Baseline to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start2 Oct 2018
- Primary completion20 Aug 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorder GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChemRar Research and Development Institute, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margarita A Morozova, MD,PhD,Prof, Principal investigator, "Research Center for Mental Health" Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524975
- Sponsor's protocol ID
- CNS-CD0080045-04
- Status last verified
- Aug 2020
- First submitted
- 15 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04524975
- Acronym / sponsor ID
- CNS-CD0080045-04
- Conditions
- Anxiety Disorder Generalized
- Keywords
- Anti-Anxiety Agents, Anxiety Disorder Generalized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- ChemRar Research and Development Institute, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CD-008-0045 60 mg/day | Experimental | Drug: CD-008-0045Patients 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 | Experimental | Drug: CD-008-0045, Drug: PlaceboPatients 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 comparator | Drug: PlaceboPatients assigned to the Placebo group will receive 1 placebo capsule before breakfast, lunch, and dinner for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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);
Key exclusion criteria (30 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD-008-0045CD-008-0045 20 mg capsules | Drug | CD-008-0045 40 mg/day, CD-008-0045 60 mg/day |
| PlaceboPlacebo capsules | Drug | CD-008-0045 40 mg/day, Placebo |
Primary outcome
Frequency of treatment response
Time frame: 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]
13 secondary outcomes
Change of the HARS total score
Time frame: Baseline to Week 8, Week 8 to Week 9
Change in the score sum of the mental and somatic anxiety subscales of HARS
Time frame: Baseline to Week 8
Change of scores in items 1 (Anxious mood) and 2 (Tension) of HARS
Time frame: Baseline to Week 8
Change of the sum of Hamilton Depression Rating Scale (HAM-D) scores
Time frame: Baseline to Week 8, Week 8 to Week 9
Change in the Clinical Global Impression - Severity Scale (CGI-S)
Time frame: Baseline to Week 8, Week 8 to Week 9
Clinical Global Impression - Improvement Scale (CGI-I)
Time frame: Week 4, Week 8, Week 9
Change of daytime somnolence level based on Visual Analogue Scale (VAS)
Time frame: Baseline to Week 8, Week 8 to Week 9
CD-008-0045 concentration prior to the next drug administration (Ctrough)
Time frame: Week 4, Week 8
M1 concentration prior to the next drug administration (Ctrough)
Time frame: Week 4, Week 8
CD-008-0045 concentration 1 hour post drug administration (Cmax)
Time frame: Week 4, Week 8
M1 concentration 1 hour post drug administration (Cmax)
Time frame: Week 4, Week 8
CYP2D6 polymorphism
Time frame: Week 4
Incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: Baseline to Week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margarita A Morozova, MD,PhD,Prof principal investigator
"Research Center for Mental Health" Scientific Institution
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD-008-0045 in people with Anxiety Disorder Generalized, run by ChemRar Research and Development Institute, LLC at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment response (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.