Schizophrenia Clinical Trial
Official title:
A Randomized Trial to Compare the Efficiency and Side Effect Between Olanzapine and Long-acting Paliperidone Palmitate Injection in Schizophrenia
Verified date | January 2018 |
Source | Beijing HuiLongGuan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized trial of olanzapine and Long-acting paliperidone palmitate injection in the treatment of 100 treatment- naive first-episode patients with schizophrenia.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 30, 2017 |
Est. primary completion date | August 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of schizophrenia or schizophreniform disorder; - Duration of symptoms not longer than 60 months; - No prior treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days; - Between 18 and 45 years of age; and - Current psychotic symptoms of moderate severity. Exclusion Criteria: - A DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform; - Documented disease of the central nervous system that can interfere with the trial assessments including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic, infection; - Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension); - A clinically significant ECG abnormality in the opinion of the investigator; - Pregnant or breast-feeding female; - Use of disallowed concomitant therapy; - History of severe allergy or hypersensitivity. |
Country | Name | City | State |
---|---|---|---|
China | Beijing HuiLongGuan Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing HuiLongGuan Hospital |
China,
Kim E, Correll CU, Mao L, Starr HL, Alphs L. Once-monthly paliperidone palmitate compared with conventional and atypical daily oral antipsychotic treatment in patients with schizophrenia. CNS Spectr. 2016 Dec;21(6):466-477. Epub 2016 Sep 15. — View Citation
Yoshimura R, Hori H, Katsuki A, Atake K. Marked Improvement of Meige Syndrome in a Japanese Male Patient with Schizophrenia After Switching from Risperidone to Paliperidone: A Case Report. J UOEH. 2016 Sep;38(3):233-6. doi: 10.7888/juoeh.38.233. — View Citation
Young-Xu Y, Duh MS, Muser E, DerSarkissian M, Faust E, Kageleiry A, Bhak RH, Fu DJ, Lefebvre P, Shiner B. Impact of Paliperidone Palmitate Versus Oral Atypical Antipsychotics on Health Care Resource Use and Costs in Veterans with Schizophrenia. J Clin Psy — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptoms assessed on PANSS. | Clinical symptoms | 12 weeks | |
Secondary | Clinical global impression assessed on CGI. | clinical severity | 12 weeks | |
Secondary | Cognitive functioning assessed on RBANS. | cognitive performance | 12 weeks | |
Secondary | Number of weight change in treatment assessed on Weight gain. | weight gain | 12 weeks | |
Secondary | Abnormal Involuntary Movement Scale assessed Abnormal Involuntary Movement Scale assessed on AIMS. | Side effects | 12 weeks |
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