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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: Completed Phase 3 study of Schizophrenia, sponsored by Donald C. Goff, MD.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Side effects were tracked using the Side Effect Checklist for ziprasidone, which is a well-validated 17 item scale that records the presence or absence of side effects. Total number of side effect events is reported here.
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 |
What the finished NCT00403546 record still lists
NCT00403546 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (40% lower).
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 lists 9 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT00403546's enrollment target sits among peer trials
131 115th of 315 higher than 201 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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