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Can a chinese herbal formula boost depression treatment?

NCT ID NCT07085143

Symptom relief Sponsor: Shanghai Mental Health Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether Compound Ciwujia Granules, a traditional Chinese herbal medicine, can help reduce depression symptoms in people with a specific syndrome (heart-spleen deficiency). About 60 adults with major depressive disorder will take either the granules or a placebo twice daily for 8 weeks, while continuing their usual antidepressant. The main goal is to see if the granules improve mood more than placebo, and to check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for major depressive disorder (MDD) and the depressive episode criteria of the Mini-International Neuropsychiatric Interview (M.I.N.I.); * Fulfills Traditional Chinese Medicine (TCM) diagnostic criteria for heart-spleen deficiency syndrome * HAMD-17 (17-item Hamilton Depression Rating Scale) total score: 8-24; * HAMA (Hamilton Anxiety Rating Scale) score ≤21; * Outpatient participants aged 18-65 (inclusive) of either sex; * Education level ≥ junior high school, capable of completing self-assessment scales; * Currently on a stable dose of one SSRI for ≥6 weeks, with a CGI-GI (Clinical Global Impression - Global Improvement) score ≥4 at screening and baseline; * Voluntary participation with signed informed consent. Exclusion Criteria: * Prior diagnosis or medical history of: organic mental disorder-related depression, clinically significant neurological diseases (e.g., epilepsy, encephalopathy), any neurodegenerative disorders, moderate/severe head trauma or other neurological conditions affecting CNS function; * Current DSM-5-diagnosed psychiatric disorders (other than MDD), including: Schizophrenia spectrum/other psychotic disorders, Bipolar and related disorders, Anxiety disorders, OCD, or somatic symptom disorders, Substance-related/addictive disorders (excluding caffeine/nicotine), Positive urine drug screen at screening; * Suicide risk, defined as: history of suicide attempt, investigator-assessed current significant risk, any "Yes" response to C-SSRS Items 1-5; * Severe systemic diseases, including: significant cardiac, hepatic, or renal dysfunction, ALT/AST \>1.5× upper limit of normal (ULN); * Pregnancy/lactation, or women of childbearing potential not using effective contraception; * Acute/chronic conditions within 1 month: Infectious/autoimmune diseases, allergies, cancer, or stroke; * Participation in other drug trials within 1 month; * History of:psychosurgery, deep brain stimulation (DBS), electroconvulsive therapy (ECT)

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression - major depressive disorder Depression disorders

Contacts and locations

Locations

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.