Chinese Herb for the Treatment of Depression and Anxiety Disorders

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.

Study Overview

• Status: Unknown
• Conditions: Depression, Anxiety
• Intervention / Treatment: Other: SZ-05; Drug: Escitalopram Pill

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
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Akko, Israel, 25201
    • Recruiting
    • Mazor MHC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms	Changes in HAM-D rates	Subjects will be monitored at baseline and every two weeks for six weeks
Anxiety symptoms	Changes in HAM-A rates	Subjects will be monitored at baseline and every two weeks for six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wellbeing	Changes in SDS rate	Subjects will be monitored at baseline and every two weeks for six weeks

Collaborators and Investigators

• Sponsor: Mazra Mental Health Center
• Collaborators: The Academic College of Tel-Aviv Yaffo
• Investigators: Principal Investigator: Efrat City, MD, Mazor MHC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 28, 2017
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): December 30, 2018

Study Registration Dates

• First Submitted: October 1, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (ACTUAL): October 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Herbal Medicine; SSRI; Chinese Medicine; Hamilton Scale
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: MZR-0018-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No