An interventional study of Berberine in Schizophrenia and Negative Symptoms of Schizophrenia, sponsored by Tianjin Anding Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Tianjin Anding Hospital · Not applicable, Interventional, and Treatment
Among 12 studies in Schizophrenia by Tianjin Anding Hospital — 4 open to participants now, 4 under way, none of them phase 3. Schizophrenia · Tianjin Anding Hospital.
Among the 12 studies in Schizophrenia by Tianjin Anding Hospital, this one is one of 2 that started in 2023, is one of 8 with no phase, and was the 11th registered.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 120 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →4 of the 12 studies in Schizophrenia by Tianjin Anding Hospital are open now, in 1 country. Each count lists the studies.
Of the 331 Schizophrenia studies recruiting now, 63 (19%) set no upper age limit and 257 (78%) stop at 75 or younger; 42 take children under 18; 83 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 2 started in 2023.
Median enrollment 100 across the 9 interventional studies, 300 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
Tianjin Anding Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
1 of the studies in Schizophrenia by Tianjin Anding Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07356765Tianjin Anding HospitalBerberine in Treating Negative Symptoms of Schizophrenia: Clinical Efficacy and Mechanisms | 2027-01 |
Among the 12 studies in Schizophrenia by Tianjin Anding Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
"Negative" symptoms are a major challenge for people with schizophrenia (SZ) and are a key reason why they struggle with everyday functioning. While current medications work well for the "positive" symptoms (like hallucinations or delusions), they aren't very effective at improving these "negative" symptoms, which include things like a lack of motivation or emotion. This study is designed as a large-scale, randomized, placebo-controlled, rater-blinded trial to investigate whether berberine (BBR), a chemical compound, can safely and effectively ameliorate negative symptoms in patients with schizophrenia (SZ). The investigators will also explore the effects of BBR on gut microbiota, related fecal metabolites, and systemic inflammatory status. By comparing these various biomarkers before and after BBR adjunctive treatment, the investigators aim to elucidate the mechanism of action of BBR on negative symptoms and to identify its primary therapeutic targets. This study is expected to open up novel therapeutic avenues for the treatment of negative symptoms in schizophrenia in the future.
The investigators will enroll at least 120 patients with schizophrenia (SZ) meeting the inclusion criteria, randomized 1:1 to either the experimental group receiving antipsychotic medication plus berberine (BBR) or the control group receiving antipsychotic medication, for a clinical intervention of 12 weeks. The primary outcome measures will be the change in the Negative Symptom Scale (SANS) total score and the log50 result of the skin nicotine test throughout the 12-week period. Secondary outcome measures include the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression scale (CGI), the Calgary Depression Scale for Schizophrenia (CDSS), the Global Assessment of Functioning (GAF), the Extrapyramidal Symptom Rating Scale, and cognitive assessments (MATRICS Consensus Cognitive Battery - MCCB). Other study indicators will involve the collection of sociodemographic and general clinical data. Blood and stool samples will be collected at pre-intervention (baseline), at 12 weeks of intervention, or at study termination. For safety assessments, participants' vital signs will be monitored at baseline, 4 weeks, 8 weeks, and 12 weeks, along with physical parameters (height, weight, blood pressure). Laboratory investigations will include complete blood count, comprehensive biochemical panel, and electrocardiogram (ECG). The Treatment Emergent Symptom Scale (TESS) will be used to assess drug side effects, and any adverse events will be recorded. Ultimately, the collected data will be used to investigate the clinical efficacy and safety of BBR on negative symptoms in SZ, its impact on the gut microbiota and their metabolic small molecules, its effect on peripheral blood inflammatory factors in SZ patients, and the longitudinal and cross-sectional correlations between gut microbiota and their metabolic small molecules, blood parameters, and negative symptoms in SZ patients under BBR treatment. This will facilitate the identification of early predictive biomarkers for BBR efficacy and key gut microbiota targets responsible for improving negative symptoms in SZ.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Berberine
Berberine 300 mg by mouth each dose# three times a day# plus any stable antipsychotic drug
Also known as: stable antipsychotic
Change in the total score of the Scale for Assessment of Negative Symptoms (SANS)
The Scale for Assessment of Negative Symptoms (SANS) is a clinician-rated observational scale developed by American neuropsychiatrist Nancy C. Andreasen to assess negative symptoms in schizophrenia. The scale includes categories such as alogia (poverty of speech), blunted affect, avolition, anhedonia/asociality, and attention impairment, with a focus on evaluating the patient's deficit symptoms of mental activity. Changes in the total SANS score will, to a certain extent, reflect changes in the severity of the subject's negative symptoms.
Time frame: Baseline, week4, week8, week12
log50 of the cutaneous niacin flush
In this study, the Skin Flush Meter will be utilized for the first time to quantify the attenuation of the niacin flush response, serving as an objective assessment tool for negative symptoms in schizophrenia (SZ). Building upon a pre-existing image library of niacin flush responses from a previous cohort, the research team from our collaborating unit has developed a niacin predictor device. This device largely preserves the observational steps of the original method. Based on this, previously manual simple scoring has been replaced with artificial intelligence (AI) for processing large volumes of color images. It compares pre- and post-niacin color differences in the skin, extracts variables for erythema intensity, and precisely calculates the area of irregular redness. By integrating the temporal dimension, it further achieves quantification and refinement with second-level resolution.
Time frame: Baseline, week4, week8, week12
Cognitive Function
All participants underwent cognitive function assessment based on the MATRICS Consensus Cognitive Battery (MCCB). There are 9 subtests, which mainly assess 7 cognitive domains, including information processing speed, attention/alertness, Working memory, word learning, visual memory, reasoning and problem solving, and social cognition. After the evaluation is completed, the MCCB rough score is converted into the total score T score obtained after correction for age, gender, years of education, and untreated period. The T score is then converted into a defect score, with T scores ≥ 40, 35-39, 30-34, 25-29, 20-24, and ≤ 19 corresponding to defect scores 0, 1, 2, 3, 4, and 5, respectively. Among them, 1 represents mild defects, 2 represents mild to moderate defects, 3 represents moderate defects, 4 represents moderate to severe defects, and 5 represents severe defects. In this study, a defect score of ≥ 3 was used as the boundary for significant cognitive impairment.
Time frame: Baseline, week4, week8, week12
Psychiatric Symptoms
The psychiatric symptoms of schizophrenia were assessed in all enrolled patients using the Positive and Negative Syndrome Scale (PANSS). The PANSS is a 30-item clinician-rated scale yielding a total score ranging from 30 (least symptomatic) to 210 (symptomatic), where higher scores indicate more severe psychopathology.
Time frame: Baseline, week4, week8, week12
Clinical efficacy
The Clinical Global Impression (CGI) scale is a standardized tool used to assess the severity of a patient's illness and the effectiveness of treatment. The CGI employs a 1 to 7 point graded rating scale, with two subscales: Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I). Higher CGI-S scores indicate greater illness severity. CGI-I is calculated as the difference between post-treatment and pre-treatment assessments; a higher score signifies more significant illness improvement.
Time frame: Baseline, week4, week8, week12
Depressive Symptoms
The Calgary Depression Scale for Schizophrenia (CDSS) is primarily utilized to evaluate depressive symptomatology in patients with schizophrenia. The scale consists of 9 structured items that assess: depressive mood, despair, self-deprecation, delusions of guilt, pathological guilt, diurnal variation (morning depression), early morning awakening, suicidal ideation, and observed depressive signs. Each item is rated on a 0-3 point scale, where higher scores signify increased symptom severity.
Time frame: Baseline, week4, week8, week12
Functional capacity
The Global Assessment of Functioning (GAF) Scale for individuals with schizophrenia is a specialized instrument for evaluating their functional capacity. Its purpose is to comprehensively assess the patient's functional performance in various significant life areas, such as social, occupational, and psychological functioning, as well as activities of daily living. The scale's scoring ranges from 0-100: A score of ≥ 71: Suggests generally normal social functioning, enabling regular engagement in work, study, and social activities. A score of 51-70: Implies mild impairment in social functioning, possibly characterized by diminished social interactions or reduced responsibility. A score of 31-50: Denotes significant impairment in social functioning, necessitating ongoing supervision or supportive assistance for daily living. A score of ≤ 30: Signifies severe impairment in social functioning, requiring professional therapeutic or custodial care.
Time frame: Baseline, week4, week8, week12
Changes of CRP
The concentration of C-reactive protein (CRP) is measured in venous blood. CRP is an acute-phase reactant protein synthesized by the liver, primarily functioning to recognize and clear pathogens or damaged cells. It plays a crucial role in inflammatory responses, infection surveillance, and disease monitoring.
Time frame: Baseline, week12
Fecal 16S rRNA sequencing
Fresh morning stool samples were collected from subjects at baseline, 12 weeks, or study termination using a 5ml sterile, sealed stool collection kit. Care was taken to collect from the center of the sample, avoiding contact with the external environment to prevent contamination. Within 15 minutes of collection, samples were divided into two 2ml EP tubes and stored at -80°C for fecal 16S rRNA sequencing.
Time frame: Baseline, week12
Started Sep 2023 (actual). Primary completion is estimated for Jan 2027, 40 months after the start.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's planned 40 months is above that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Berberine
Tianjin Anding Hospital