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NCT00403546 · ClinicalTrials.gov registry record · Phase 3
High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
A Phase 3 study of Schizophrenia, sponsored by Donald C. Goff, MD.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
- 9
- Study locations
NCT00403546 is a Phase 3 study of Schizophrenia that has completed, run by Donald C. Goff, MD. The registered enrollment target is 131 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (40% lower). The trial reports 9 study locations across 7 states.
The verdict
NCT00403546, a Phase 3 study of Schizophrenia, has completed, sponsored by Donald C. Goff, MD.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
- 9
- Study locations
Study Summary
The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG) and completion rates and to assess whether ziprasidone dose escalation improves overall psychopathology compared to continued standard treatment as measured by the change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates as defined by a 20% or greater reduction in PANSS total score. The secondary aims of this study are to assess whether ziprasidone dose escalation improves psychotic symptoms compared to continued standard treatment as measured by the Positive Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms compared to continued standard treatment as measured by the Calgary Depression Rating Scale (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement (CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale (SCoRS).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ziprasidone 80-160 mg/d
- DRUG Ziprasidone 160 mg/d
Study Locations (9)
New York
- SUNY Downstate Medical Center - Brooklyn
- The Lieber Center for Schizophrenia Research - Columbia University - New York
- Nathan Kline Institute - Orangeburg
Georgia
- Medical College of Georgia - Augusta
Massachusetts
- Corrigan Mental Health Center - Fall River
Michigan
- Touchstone innovare - Grand Rapids
New Mexico
- University of New Mexico - Albuquerque
North Carolina
- Duke University - John Umstead Hospital - Butner
Texas
- The Mech Center - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00403546
The ClinicalTrials.gov registry entry for NCT00403546 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (40% lower). The listed sponsor is Donald C. Goff, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00403546 reports 9 study locations spanning 7 distinct geographic areas - top geographies include New York, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00403546 about?
NCT00403546 is a clinical study titled "High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms". The primary aims of this study are to assess tolerability of ziprasidone dose escalation to 320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes Akathisia Scale (BAS), ...
What is the current status of trial NCT00403546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2006-01. Estimated completion is 2011-05.
What conditions does trial NCT00403546 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT00403546?
The interventions under investigation include: Placebo (DRUG), Ziprasidone 80-160 mg/d (DRUG), Ziprasidone 160 mg/d (DRUG).
Who is sponsoring clinical trial NCT00403546?
This trial is sponsored by Donald C. Goff, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00403546 being conducted?
This trial has 9 study locations across Georgia, Massachusetts, Michigan, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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