Chinese Herb for the Treatment of Depression and Anxiety Disorders

Sponsor

Mazra Mental Health Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03323697

Collaborator

The Academic College of Tel-Aviv Yaffo (Other)

Enrollment

Location

Arms

16.1

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind controlled trialRandomized, 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 :

Aug 28, 2017

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 30, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Anxiety symptoms [Subjects will be monitored at baseline and every two weeks for six weeks]
Changes in HAM-A rates
Depressive symptoms [Subjects will be monitored at baseline and every two weeks for six weeks]
Changes in HAM-D rates

Secondary Outcome Measures

Wellbeing [Subjects will be monitored at baseline and every two weeks for six weeks]
Changes in SDS rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.