Status:
UNKNOWN
Efficacy and Safety of Ziprasidone to Treat Depressive Symptoms in Patients With Schizophrenia
Lead Sponsor:
Wuhan University
Collaborating Sponsors:
Peking University
Pfizer
Conditions:
The Primary Evaluation is the Change From Baseline at End of Study for CDSS Total Scores.
The Secondary Efficacy Evaluations Include: MADRS, PANSS Total Scores and Subscales and Responder Rate; CGI-S and CGI-I Scales.
Eligibility:
All Genders
18-65 years
Brief Summary
This study is going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study will be carried out at 2 mental centers in China...
Detailed Description
Primary objective The primary objective was to evaluate the efficacy of ziprasidone in the treatment of depressive symptoms in patients with schizophrenia. Secondary objectives The secondary objectiv...
Eligibility Criteria
Inclusion
- (1).First-episode or non-refractory recurrent male or female in-hospitalized subjects (aged 18 to 65 years) with a diagnosis of schizophrenia and a minimum score of 70 on the Positive and Negative Syndrome Scale (PANSS) at randomization. First-episode is defined as duration of illness from the onset of psychotic symptoms ranged from 3 days to 36 months and without systemic treatment. Refractory is defined as failure to experience a therapeutic response during acute exacerbation following adequate trials of marketed antipsychotic agents on two or more occasions during the two years prior to study entry.
- (2).Patients who meet DSM-IV-TR criteria for schizophrenia and have been diagnosed as having "295.XX schizophrenia".
- (3).Patients with a CDSS total score of 5 or more in screening visit and baseline visit.
- (4).Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
Exclusion
- (1).Patients who have received systemic treatment of any antipsychotics or antidepressants within 12 weeks prior to informed consent.
- (2).Women who are pregnant, possibly pregnant, or breast-feeding. (3).Patients with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance.
- (4).Patients who have met DSM-IV-TR criteria for a substance-related disorder within 3 months (90 days) prior to informed consent (excluding caffeine- and nicotine-related disorders but including abuse of benzodiazepines) (5).Patients who have received ECT treatment within 8 weeks prior to informed Consent.
- (6).Patients who have used supplements containing centrally-acting substances (tryptophan, St. John's wort) within 4 weeks prior to informed consent.
- (7).Patients with unstable thyroid disorder (hypothyroidism, hyperthyroidism) or those who have received thyroid treatment within 3 months (90 days) prior to informed consent.
- (8).Patients considered to be unresponsive to clozapine (9).Patients at significant risk of developing a severe adverse event. Patients who have a medical condition that would interfere with assessments of safety or efficacy during the course of the study, or who have a history of such a condition. For example, patients diagnosed as having a complication of serious hepatic, renal, cardiac, or hematopoietic disorder, such as those described below, within 4 weeks prior to informed consent or during the screening period Hepatic disorder: Total bilirubin≥3.0 mg/dL, AST (GOT) and ALT(GPT)≥2.5 times the upper limits of normal levels Renal disorder: Creatinine ≥ 2 mg/dL Cardiac disorder: patients with a known history of QT prolongation (including congenital long QT syndrome); patients with recent acute myocardial infarction; patients with uncompensated heart failure (10).Patients known to have a history or complication of allergy to ziprasidone or other quinolinone-skeleton compounds (11).Patients with a history or a complication of neuroleptic malignant syndrome (12).Patients who represent a significant risk of committing suicide (13).Patients with a history or a complication of organic brain disorder or convulsive disorder, such as epilepsy
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01260116
Start Date
December 1 2010
End Date
March 1 2012
Last Update
December 15 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.