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Clinical study of Yueju pill combined with olanzapine in the treatment of negative symptoms of schizophrenia

Clinical study of Yueju pill combined with olanzapine in the treatment of negative symptoms of schizophrenia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005104
Enrollment
Unknown
Registered
2021-07-28
Start date
2021-08-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Sponsors

Mental Health Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of the International Classification of Diseases (ICD-10) for schizophrenia; 2. In line with the dialectical treatment of epilepsy syndrome of liver-qi stagnation and phlegm-qi stagnation in TCM internal medicine; 3. Take olanzapine before entering the group, the dose will be stable for more than 2 weeks, and the treatment plan will remain unchanged during the study period; 4. Positive and Negative Psychiatric Symptom Scale (PANSS) > 60 points, and Negative Symptom Scale (SANS) total score >= 50 points at the time of enrollment; 5. Gender is not limited, aged 18-65 years; 6. The informed consent form for participating in this study shall be signed by the subjects themselves or their legal guardians.

Exclusion criteria

Exclusion criteria: 1. Serious physical disease, organic brain disease, traumatic brain injury, etc.; 2. Psychotic symptoms secondary to other physical diseases; 3. There is a clear risk of suicide or endangerment to self or others; 4. Patients with Yin deficiency and internal heat type diagnosed by TCM pulse diagnosis; 5. Two or more items >= 4 points (P1, P3, P5, P6, G9); 6. Calgary Schizophrenia Depression Scale total score > 6; 7. The sum of the first 8 items on the Simpson Angus Scale (SAS) is >3; 8. Meets ICD-10 diagnosis of any other psychiatric disorder.

Design outcomes

Primary

MeasureTime frame
Scale of negative symptoms(SANS);

Secondary

MeasureTime frame
Positive and negative syndrome scale;Blood dopamine;Event-related potentials;Side effect scale;Blood brain-derived neurotrophic factor;Gross clinical impression scale;Blood gamma-aminobutyric acid;TCM symptom scale;Blood glutamic acid;Clinical assessment interview for negative symptoms(CAINS);Blood 5-hydroxytryptamine;

Countries

China

Contacts

Public ContactZhao Jing

Mental Health Center, Shanghai Jiao Tong University School of Medicine

maggy-1978@163.com+86 18017311160

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026