Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc. Clinical Trial
Official title:
Efficacy and Safety of Ziprasidone in the Treatment of Depressive Symptoms in Patients With Schizophrenia：an 8-week Open-label Study
| Verified date | December 2010 |
| Source | Wuhan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China:Renmin hospital of Wuhan University |
| Study type | Observational |
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. Subjects will be required to attend the center at screening, baseline,
Weeks 1, 2, 4 ,6 and 8 or early termination visit.
At screening, patients underwent psychiatric and physical examination, standard lab tests,
and an Electrocardiograph.
At baseline, if they continued to be eligible, they began ziprasidone 20 mg twice daily.
Depending on response and tolerability, ziprasidone could be gradually escalated to a
maximum of 80 mg twice daily.
| Status | Not yet recruiting |
| Enrollment | 120 |
| Est. completion date | March 2012 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - (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 Criteria: - (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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Wuhan University | Peking University, Pfizer |