Chinese Herb for the Treatment of Depression and Anxiety Disorders

NCT03323697 | Unknown Phase 1

• 1 other identifier: MZR-0018-016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Keywords

Depression; Anxiety; Herbal Medicine; Chinese Medicine; Hamilton Scale; SSRI

Outcome Measures

Primary Outcomes (2)

• Anxiety symptoms

  Changes in HAM-A rates

  Subjects will be monitored at baseline and every two weeks for six weeks

• Depressive symptoms

  Changes in HAM-D rates

  Subjects will be monitored at baseline and every two weeks for six weeks

Secondary Outcomes (1)

• Wellbeing

  Subjects will be monitored at baseline and every two weeks for six weeks

Study Arms (2)

Herbal

EXPERIMENTAL

SZ-05 (2.5 gr; 3 capsules twice a day)

Other: SZ-05

Selective serotonin reuptake inhibitor

ACTIVE COMPARATOR

Escitalopram (10 mg capsule plus 5 placebo capsules)

Drug: Escitalopram Pill

Interventions

SZ-05 OTHER

2.5g a day (3 capsules twice a day)

Also known as: no other names

Herbal

Escitalopram Pill DRUG

10 mg capsule plus 5 placebo capsules

Also known as: no other names

Selective serotonin reuptake inhibitor

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazra Mental Health Center: lead
• The Academic College of Tel-Aviv Yaffo: collaborator

Study Sites (1)

Mazor MHC

Acre, 25201, Israel

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Efrat City, MD

  Mazor MHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alon Shamir, Ph.D

CONTACT

+97249954708; alons@mazor.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind controlled trial

Study Record Dates

• First Submitted: October 1, 2017
• First Posted: October 27, 2017
• Study Start: August 28, 2017
• Primary Completion: September 1, 2018
• Study Completion: December 30, 2018
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)