MedTrace Logo

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

NCT01260116 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2010-12-15

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Wuhan University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-10-31
Completion
2012-03-31

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01260116 on ClinicalTrials.gov