Clinical trial NCT03323697: Chinese Herb for the Treatment of Depression and Anxiety Disorders
Official title: The Chinese Herb SZ-05 for the Treatment of Depression and Anxiety Disorders; Efficiency, Safety and Biological Correlates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Depression, Anxiety
Keywords: Depression
Anxiety
Herbal Medicine
Chinese Medicine
Hamilton Scale
SSRI
Lead sponsor: Mazra Mental Health Center
Sponsor class: OTHER
Collaborators: name: The Academic College of Tel-Aviv Yaffo
First posted: 2017-10-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anxiety symptoms
timeFrame: Subjects will be monitored at baseline and every two weeks for six weeks
measure: Depressive symptoms
timeFrame: Subjects will be monitored at baseline and every two weeks for six weeks
Secondary outcomes:
measure: Wellbeing
timeFrame: Subjects will be monitored at baseline and every two weeks for six weeks
Other outcomes:
Locations:
city: Akko
country: Israel
facility: Mazor MHC
Study officials:
affiliation: Mazor MHC
name: Efrat City, MD
role: PRINCIPAL_INVESTIGATOR
References: