Chinese Herb for the Treatment of Depression and Anxiety Disorders

NCT ID: NCT03323697

Last Updated: 2017-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-28
• Study Completion Date: 2018-12-30

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.

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

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Herbal

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

Group Type: EXPERIMENTAL

SZ-05

Intervention Type: OTHER

2.5g a day (3 capsules twice a day)

Selective serotonin reuptake inhibitor

Escitalopram (10 mg capsule plus 5 placebo capsules)

Group Type: ACTIVE_COMPARATOR

Escitalopram Pill

Intervention Type: DRUG

10 mg capsule plus 5 placebo capsules

Interventions

SZ-05

2.5g a day (3 capsules twice a day)

Intervention Type: OTHER

Escitalopram Pill

10 mg capsule plus 5 placebo capsules

Intervention Type: DRUG

Other Intervention Names

no other names; no other names

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Academic College of Tel-Aviv Yaffo

OTHER

Sponsor Role: collaborator

Mazra Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Efrat City, MD

Role: PRINCIPAL_INVESTIGATOR

Mazor MHC

Locations

Mazor MHC

Acre, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Alon Shamir, Ph.D

Role: CONTACT

Phone: +97249954708

Email: alons@mazor.health.gov.il

Facility Contacts

Alon Shamir, Ph.D

Role: primary

Other Identifiers

MZR-0018-016

Identifier Type: -

Identifier Source: org_study_id