A Phase 1/2 interventional study of SZ-05 and Escitalopram Pill in Depression, Anxiety, sponsored by Mazra Mental Health Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Mazra Mental Health Center · Phase 1/2, Interventional, and Treatment
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Among 72 studies in Depression with a site in Israel — 8 open to participants now, 10 under way, none of them phase 3. Depression · Israel.
Among the 72 studies in Depression with a site in Israel, this one is the 28th largest by planned enrollment of the 56 interventional ones that give a count, is one of 3 that started in 2017, is one of 3 in phase 1/2, and was the 46th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →8 of the 72 studies in Depression with a site in Israel are open now. Recruiting first, the newest first:
GrayMatters Health Ltd. · Sites in Israel, United States
Ages 22–75
Hebrew University of Jerusalem · Sites in Israel
Ages 65+ · Healthy volunteers
Assaf-Harofeh Medical Center · Sites in Israel
Ages 50–85
Bar-Ilan University, Israel · Sites in Israel, United States
Ages 18+
HaEmek Medical Center, Israel · Sites in Israel
Ages 18+
A study can be open while its sites in Israel have not opened yet or have stopped. Only those recruiting at a site in Israel →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 4 · Phase 4 6
First in 2003; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 60 across the 56 interventional studies, 200 across the 16 observational. Of the 31 that completed or were terminated, 1 (3%) have results posted.
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4 of 72 have an industry lead sponsor. The 10 most frequent:
Mazra Mental Health Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
Mazra Mental Health Center has 1 study filed under Depression — fewer than ten, so there is no comparison to draw.
2 of the studies in Depression with a site in Israel that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06982820GrayMatters Health Ltd.Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia | 2027-05-30 |
| NCT07913425University of HaifaExamining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents | 2027-06-30 |
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Among the 72 studies in Depression with a site in Israel, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SZ-05 (2.5 gr; 3 capsules twice a day)
Other: SZ-05
Escitalopram (10 mg capsule plus 5 placebo capsules)
Drug: Escitalopram Pill
2.5g a day (3 capsules twice a day)
Also known as: no other names
10 mg capsule plus 5 placebo capsules
Also known as: no other names
Anxiety symptoms
Changes in HAM-A rates
Time frame: Subjects will be monitored at baseline and every two weeks for six weeks
Depressive symptoms
Changes in HAM-D rates
Time frame: Subjects will be monitored at baseline and every two weeks for six weeks
Wellbeing
Changes in SDS rate
Time frame: Subjects will be monitored at baseline and every two weeks for six weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2017 (actual). Primary completion is estimated for Sep 2018, 12 months after the start.
Of 42 phase 1/2 interventional studies under Depression, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Mazra Mental Health Center