Schizophrenia Clinical Trial
Official title:
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
NCT number | NCT04432688 |
Other study ID # | DSPCLAT-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2020 |
Est. completion date | June 18, 2023 |
Verified date | April 2024 |
Source | Sumitomo Pharma (Suzhou) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
It's a prospective, non-interventional, observational Post-marketing Surveillance..
Status | Completed |
Enrollment | 3192 |
Est. completion date | June 18, 2023 |
Est. primary completion date | March 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Schizophrenia Patients who begin to receive Latuda® Exclusion criteria: - No exclusion criteria |
Country | Name | City | State |
---|---|---|---|
China | Beijing Anding Hospital | Beijing | Beijing |
China | Brain Hospital of Hunan Province | Changsha | Hunan |
China | The first specialized hospital of Harbin | Harbin | Heilongjiang |
China | Shandong Mental Health Center | Jinan | Shandong |
China | Shanghai Mental Health Center | Shanghai | Shanghai |
China | First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | Tianjin Anding Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Sumitomo Pharma (Suzhou) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of Adverse Event | Adverse events | week 12 | |
Secondary | The incidence of extrapyramidal symptom | Extrapyramidal Symptoms (EPS) are drug-induced movement disorders that accur due to antipsychotic blockade of the nigrostriatal dopamine tracts, including acute dystonia, akathisia, antipsychotic-induced parkinsonism, tardive dyskinesia (TD) | baseline/ week 2-4/ week 6-8/ week 12 | |
Secondary | The incidence of akathisia | Akathisia is a side effect of antipsychotic drugs, presenting as restlessness, fidgeting of the legs, rocking, pacing, and the inability to sit or stand still. | baseline/ week 2-4/ week 6-8/ week 12 | |
Secondary | the rate of use of extrapyramidal symptom treatment drugs | extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects | baseline/ week 2-4/ week 6-8/ week 12 | |
Secondary | Changes in body weight at the end of treatment compared with baseline | Weight is measured on a scale | baseline/ week 12 | |
Secondary | The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline | Brief Psychiatric Rating Scale (BPRS) is a generic scale developed to measure clinical change in patients with schizophrenia and which can be used as a global measure of psychopathology. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = "not present" to 7 = "extremely severe", with scores ranging from 18 to 126 (achieved through summing the item scores). | baseline/ week 2-4/ week 6-8/ week 12 |
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