Depression, AnxietyPhase 1/2NCT03323697
Chinese Herb for the Treatment of Depression and Anxiety Disorders
A Phase 1/2 study testing SZ-05 and Escitalopram Pill in people with Depression, Anxiety, run by Mazra Mental Health Center at 1 site in Israel.
Trial summary
Anxiety and depression are currently among the ten most important public health concerns, and in recent years, have reached epidemic proportions. Anxiety is recognized as the main risk factor for many diseases including cardiovascular, metabolic and neuropsychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- SZ-05 and Escitalopram Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Aug 2017to 30 Dec 2018
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes suffering from mild to moderate depressive episode of major depressive disorder (MDD) according to Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-V.
- Subjects of both sexes meeting the DSM-V criteria for dysthymia.
- Patients of both sexes meeting the DSM-V criteria for Generalized Anxiety Disorder (GAD), Panic Disorder and Social Anxiety Disorder, Adjustment disorder.
- Age 18-65.
- Not receiving antidepressant drugs.
- Hamilton Depression Rating Scale (HAM-D) scores are ≥8 and ≤ 18.
- Hamilton Anxiety Rating Scale (HAM-A) scores ≥17 and ≤ 30.
Who cannot join
- Current active and persistent substance and/or alcohol abuse.
- Mental retardation
- Other major psychiatric disorders: Psychosis, Severe MDD and Bipolar disorder
- Suicide ideation
- Pregnancy
- Systolic Blood Pressure < 100 mm Hg
- Heart rate < 60 times/min
- Patient with medical history of cardiac palpitation and other cardiac diseases
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Mazor MHC
Acre, 25201
Alon Shamir, Ph.D, +97249954708, alons@mazor.health.gov.il
About this study
Official title: The Chinese Herb SZ-05 for the Treatment of Depression and Anxiety Disorders; Efficiency, Safety and Biological Correlates
Anxiety and depression are currently among the ten most important public health concerns, and in recent years, have reached epidemic proportions. Anxiety is recognized as the main risk factor for many diseases including cardiovascular, metabolic and neuropsychiatric disorders. Current anxiolytic medications have a relatively low success rate (~50%) and are associated with many deleterious side-effects. The investigators aim to investigate the efficacy, safety, and tolerability of a novel herbal treatment on anxiety and depression symptoms in a 6-week double-blind randomized trial.
Read the detailed description
The relationship between depression and anxiety disorders has long been described, and comorbid depression and anxiety are highly prevalent conditions. The current study will focus on mild to moderate depressive and anxiety symptoms and include a variety of individuals from the depression and anxiety spectrum disorders.The objectives of the current study are to evaluate the antidepressant and anxiolytic efficacy of SZ-05 treatment in a 6-week double-blind randomized trial, and underlying the molecular mechanisms.
Clinical trial study design:
A randomized, double-blind controlled trial will be performed. Patients will be randomized to SZ-05 (2.5 gr (14); 2-3 capsules twice a day, and 1 placebo capsule) or escitalopram (10 mg capsule plus 5 placebo capsules at the same regime as SZ-05) daily treatment at a ratio of 2:1. Overall the study will be conducted for 8 weeks, and will include six weeks of double-blind controlled trial, followed by two weeks of escitalopram treatment. 30 patients will be enrolled to each arm of the trial (overall 60 patients will be recruited). After baseline evaluation and signing informed consent, subjects will be asked to fill a socio-demographic questionnaire, and to undergo a clinical differential diagnosis using the Symptoms Check List (SCL)-90, Clinical Global Impression (CGI), Hamilton anxiety rating scale (HAM-A), Hamilton depression rating scale (HAM-D), Sheehan Disability Scale (SDS), and two visual analogue scales (VAS)- general anxiety, and mood. Subjects will be monitored at baseline and every two weeks for six weeks, and every week in the last two weeks of the trial using HAM-A, HAM-D, VASs and SDS. Adverse effects will be documented every evaluation using the Treatment Emergent Symptom Scale. Subjects will be monitoring for heart rate and blood pressure at baseline and every week till the end of the trial. The herbal treatment and escitalopram will be added to the current drug treatment (non-antidepressant). Any change in the patient non-antidepressant treatment is required to be reported to the study personnel.
- Conditions
- Depression, Anxiety
- Being tested
- SZ-05, Escitalopram Pill
- Keywords
- Depression, Anxiety, Herbal Medicine, Chinese Medicine, Hamilton Scale, SSRI
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZ-05Other
Also called no other names
2.5g a day (3 capsules twice a day)
Escitalopram PillDrug
Also called no other names
10 mg capsule plus 5 placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Herbal | Experimental | SZ-05 (2.5 gr; 3 capsules twice a day) Receives: Other: SZ-05 |
| Selective serotonin reuptake inhibitor | Active comparator | Escitalopram (10 mg capsule plus 5 placebo capsules) Receives: Drug: Escitalopram Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms
Changes in HAM-A rates
Measured: Subjects will be monitored at baseline and every two weeks for six weeks
Depressive symptoms
Changes in HAM-D rates
Measured: Subjects will be monitored at baseline and every two weeks for six weeks
Secondary outcomes (1)
Wellbeing
Changes in SDS rate
Measured: Subjects will be monitored at baseline and every two weeks for six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start28 Aug 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mazra Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Academic College of Tel-Aviv Yaffo
- Responsible party
- Sponsor
- Investigators
- Efrat City, MD, Principal investigator, Mazor MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323697
- Sponsor's protocol ID
- MZR-0018-016
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2017
- Last updated
- 27 Oct 2017
- 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 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese Herb SZ-05 for the Treatment of Depression and Anxiety Disorders; Efficiency, Safety and Biological Correlates
- ClinicalTrials.gov ID
- NCT03323697
- Acronym / sponsor ID
- MZR-0018-016
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Herbal Medicine, Chinese Medicine, Hamilton Scale, SSRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mazra Mental Health CenterUniversity, hospital or other
- Collaborators
- The Academic College of Tel-Aviv Yaffo
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 27 Oct 2017 (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.
Anxiety and depression are currently among the ten most important public health concerns, and in recent years, have reached epidemic proportions. Anxiety is recognized as the main risk factor for many diseases including cardiovascular, metabolic and neuropsychiatric disorders. Current anxiolytic medications have a relatively low success rate (~50%) and are associated with many deleterious side-effects. The investigators aim to investigate the efficacy, safety, and tolerability of a novel herbal treatment on anxiety and depression symptoms in a 6-week double-blind randomized trial.
Detailed description
The relationship between depression and anxiety disorders has long been described, and comorbid depression and anxiety are highly prevalent conditions. The current study will focus on mild to moderate depressive and anxiety symptoms and include a variety of individuals from the depression and anxiety spectrum disorders.The objectives of the current study are to evaluate the antidepressant and anxiolytic efficacy of SZ-05 treatment in a 6-week double-blind randomized trial, and underlying the molecular mechanisms.
Clinical trial study design:
A randomized, double-blind controlled trial will be performed. Patients will be randomized to SZ-05 (2.5 gr (14); 2-3 capsules twice a day, and 1 placebo capsule) or escitalopram (10 mg capsule plus 5 placebo capsules at the same regime as SZ-05) daily treatment at a ratio of 2:1. Overall the study will be conducted for 8 weeks, and will include six weeks of double-blind controlled trial, followed by two weeks of escitalopram treatment. 30 patients will be enrolled to each arm of the trial (overall 60 patients will be recruited). After baseline evaluation and signing informed consent, subjects will be asked to fill a socio-demographic questionnaire, and to undergo a clinical differential diagnosis using the Symptoms Check List (SCL)-90, Clinical Global Impression (CGI), Hamilton anxiety rating scale (HAM-A), Hamilton depression rating scale (HAM-D), Sheehan Disability Scale (SDS), and two visual analogue scales (VAS)- general anxiety, and mood. Subjects will be monitored at baseline and every two weeks for six weeks, and every week in the last two weeks of the trial using HAM-A, HAM-D, VASs and SDS. Adverse effects will be documented every evaluation using the Treatment Emergent Symptom Scale. Subjects will be monitoring for heart rate and blood pressure at baseline and every week till the end of the trial. The herbal treatment and escitalopram will be added to the current drug treatment (non-antidepressant). Any change in the patient non-antidepressant treatment is required to be reported to the study personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind controlled trial
| Arm | Type | Receives |
|---|---|---|
| Herbal | Experimental | Other: SZ-05SZ-05 (2.5 gr; 3 capsules twice a day) |
| Selective serotonin reuptake inhibitor | Active comparator | Drug: Escitalopram PillEscitalopram (10 mg capsule plus 5 placebo capsules) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes suffering from mild to moderate depressive episode of major depressive disorder (MDD) according to Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-V.
- Subjects of both sexes meeting the DSM-V criteria for dysthymia.
- Patients of both sexes meeting the DSM-V criteria for Generalized Anxiety Disorder (GAD), Panic Disorder and Social Anxiety Disorder, Adjustment disorder.
- Age 18-65.
- Not receiving antidepressant drugs.
Key exclusion criteria (8 listed)
- Current active and persistent substance and/or alcohol abuse.
- Mental retardation
- Other major psychiatric disorders: Psychosis, Severe MDD and Bipolar disorder
- Suicide ideation
- Pregnancy
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 |
|---|---|---|
| SZ-05Also: no other names2.5g a day (3 capsules twice a day) | Other | Herbal |
| Escitalopram PillAlso: no other names10 mg capsule plus 5 placebo capsules | Drug | Selective serotonin reuptake inhibitor |
Primary outcome
Anxiety symptoms
Time frame: Subjects will be monitored at baseline and every two weeks for six weeks
Changes in HAM-A rates
Depressive symptoms
Time frame: Subjects will be monitored at baseline and every two weeks for six weeks
Changes in HAM-D rates
1 secondary outcome
Wellbeing
Time frame: Subjects will be monitored at baseline and every two weeks for six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- 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.
Efrat City, MD principal investigator
Mazor MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SZ-05 and Escitalopram Pill in people with Depression, Anxiety, run by Mazra Mental Health Center at 1 site in Israel.
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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alon Shamir, Ph.D (+97249954708, alons@mazor.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety symptoms (time frame: Subjects will be monitored at baseline and every two weeks for six weeks). The study lists 2 primary outcomes in all. 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 27 Oct 2017.