Schizophrenia Clinical Trial
Official title:
Early Predictors of Poor Treatment Response in Patients With Schizophrenia Treated With Atypical Antipsychotics
NCT number | NCT03730857 |
Other study ID # | T1-02 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | December 2008 |
Verified date | February 2019 |
Source | Calo Psychiatric Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: The aims of this study were to explore the relationship between early reduction
in psychotic symptoms and the ultimate response in patients with schizophrenia treated by
atypical antipsychotics, and to determine the best time to switch or maitain the regimen. PI
also explore the possible predictors for the clinical response.
Methods: One hundred eleven inpatients with acutely exacerbated schizophrenia were randomized
to give optimal therapy of olanzapine, risperidone, and paliperidone in one-week run-in
period and 12 weeks' intervention. All participants were assessed using Positive and Negative
Syndrome Scale (PANSS). Early Response, defined as reduction of 25% in PANSS score, was
examined at weeks 1, 2, 3, 4 and 8, and these ratings were used to predict ultimate response
(25% PANSS reduction) at week 12. PI hypothesized that early treatment response at Week 1 or
2 could predict Week 12's treatment outcome.
Status | Completed |
Enrollment | 111 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - (1) age 18 to 65 years, - (2) no major systemic illnesses based on physical examinations and laboratory test results, - (3) baseline PANSS total score?60 Exclusion Criteria: - (1) participants not taking any antipsychotics in the previous one month, - (2) participants were pregnant and lactating women, - (3) history of clozapine treatment in the previous 3 months, - (4) patients receiving long-acting antipsychotic injections in the preceding 6 months of enrollment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Calo Psychiatric Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive and Negative Syndrome Scale (PANSS) | The Positive and Negative Syndrome Scale (PANSS) rating scale was used to evaluate the changes of psychiatric symptoms in each time point. The raters in the present study had worked mainly on inpatient treatment of severe schizophrenic patients, and were well acquainted with symptoms of schizophrenia. | 12 weeks |
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