NCT01260116

Efficacy and Safety of Ziprasidone to Treat Depressive Symptoms in Patients With Schizophrenia

Efficacy and Safety of Ziprasidone in the Treatment of Depressive Symptoms in Patients With Schizophrenia：an 8-week Open-label Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Wuhan University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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.

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 objective was to evaluate the efficacy and the safety and tolerability of ziprasidone in the treatment of schizophrenic patients with depressive symptoms. Study design This study was going to determine the efficacy, tolerability and safety of ziprasidone in 120 schizophrenic patients with depressive symptoms. The study was carried out at 2 mental centers in China. Subjects were 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. Dosage/Administration At baseline subjects received study drug according to the following regimen: Day 1-2: ziprasidone 20 mg twice daily. Day 3-4: ziprasidone 40 mg twice daily. Day 5-6: ziprasidone 60 mg twice daily. Day 7-Week 8: ziprasidone 40, 60 or 80 mg twice daily. At visit 3 (week 1) the dosage of study drug was titrated up or down based on the clinical status of the subject and the safety and tolerability of the study drug. Subjects received all study drugs with food and under supervision. Treatment Duration It's a 8 weeks' study. There are 7 visits in this study. Visit 1 is screening visit; Visit 2 is baseline visit; Visit 3 is Week 1; Visit 4 is Week 2; Visit 5 is Week 4; Visit 6 is Week 6; Visit 7 is Week 8.

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.
• Safety Evaluations Include: Laboratory Test Abnormalities; BARS and SAS; Physical Examinations; Vital Signs; Electrocardiogram,Etc.
• Subjective Well-being Under Neuroleptics Short Form Will be Used in Our Study to Assess the Subjective Side-effects.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2012-03-01
• First posted: 2010-12-15
• Last updated: 2010-12-15