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Chinese Herb for the Treatment of Depression and Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT03323697
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
The Academic College of Tel-Aviv Yaffo
Information provided by (Responsible Party):
Mazra Mental Health Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Other: SZ-05 Drug: Escitalopram Pill Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Chinese Herb SZ-05 for the Treatment of Depression and Anxiety Disorders; Efficiency, Safety and Biological Correlates
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Herbal
SZ-05 (2.5 gr; 3 capsules twice a day)
Other: SZ-05
2.5g a day (3 capsules twice a day)
Other Name: no other names

Active Comparator: Selective serotonin reuptake inhibitor
Escitalopram (10 mg capsule plus 5 placebo capsules)
Drug: Escitalopram Pill
10 mg capsule plus 5 placebo capsules
Other Name: no other names




Primary Outcome Measures :
  1. Anxiety symptoms [ Time Frame: Subjects will be monitored at baseline and every two weeks for six weeks ]
    Changes in HAM-A rates

  2. Depressive symptoms [ Time Frame: Subjects will be monitored at baseline and every two weeks for six weeks ]
    Changes in HAM-D rates


Secondary Outcome Measures :
  1. Wellbeing [ Time Frame: Subjects will be monitored at baseline and every two weeks for six weeks ]
    Changes in SDS rate



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323697


Contacts
Contact: Alon Shamir, Ph.D +97249954708 alons@mazor.health.gov.il

Locations
Israel
Mazor MHC Recruiting
Akko, Israel, 25201
Contact: Alon Shamir, Ph.D    +97249954708    alons@mazor.health.gov.il   
Sponsors and Collaborators
Mazra Mental Health Center
The Academic College of Tel-Aviv Yaffo
Investigators
Principal Investigator: Efrat City, MD Mazor MHC

Responsible Party: Mazra Mental Health Center
ClinicalTrials.gov Identifier: NCT03323697     History of Changes
Other Study ID Numbers: MZR-0018-016
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mazra Mental Health Center:
Depression
Anxiety
Herbal Medicine
Chinese Medicine
Hamilton Scale
SSRI

Additional relevant MeSH terms:
Physiological Effects of Drugs
Psychotropic Drugs
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Serotonin Uptake Inhibitors
Dexetimide
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents