Trial · NCT00403546

High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms

NCT00403546, Phase 3, Completed, Donald C. Goff, MD; results first posted 2017-06-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms. Trials, record NCT00403546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00403546

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
NCT number: NCT00403546
Status: Completed
Phases: Phase 3
Enrollment: 131 participants, actual
Lead sponsor: Donald C. Goff, MD
Conditions: Schizophrenia
Interventions: Ziprasidone 80-160 mg/d, Placebo, Ziprasidone 160 mg/d
First posted: 2006-11-23
Last updated: 2017-06-06
Results first posted: 2017-06-06

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial	From Baseline up to Week 8	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.
Primary	Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	Baseline, Week 2, Week 4, Week 6, Week 8	The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.
Primary	Change From Baseline in the Barnes Akathisia Scale (BAS)	Baseline, Week 2, Week 4, Week 6, Week 8	BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0 - 3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0 - 5. Total score ranges from 0 to 14 with a higher score indicating increased severity. A positive change from baseline indicates a worse outcome.
Primary	Number of Participants With High and Low Levels in Serum Prolactin Concentration	Baseline, Week 8	Blood samples were taken at baseline and Week 8 to measure serum prolactin concentrations. Normal range for females (non-pregnant) is 2-29 nanograms per deciliter (ng/dL) and for males 2-18 ng/dL. Values above the normal range were reported as High and values below the normal range were reported as Low. Reported here is the number of participants with high prolactin concentration and the number of participants with low prolactin concentration.
Primary	Vital Signs: Systolic and Diastolic Blood Pressure Levels	Baseline, Week 1, Week 2, Week 4, Week 6, Week 8	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at regular times during the study. Normal SBP is defined as 120 millimeters of mercury (mmHg) or below and normal DBP is defined as 80 mmHg or below. Change from baseline is indicated for each time point. A positive change from baseline indicates and increase in blood pressure and a negative change from baseline indicates a decrease.
Primary	Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)	6 hours after dosing of Weeks 1, 2 and 8	QT interval is a measure of the time between the start of the Q wave and the end of the T wave as determined by electrocardiogram (EKG). The corrected QT Interval (QTc) adjusts the QT interval for heart rate. The number of participants with an increase to QTc interval \>/= 500 msec was reported.
Primary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, Week 2, Week 4, Week 6, Week 8	The PANSS is a medical scale and was used for measuring symptom severity of participants with schizophrenia in this study. Total PANSS score consists of 7 items in the Negative subscale, 7 items in the Positive subscale and 16 items in the General Psychopathology scale. Total PANSS score ranges from 30 to 210. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.
Primary	Percentage of Participants With Response	Baseline, Week 2, Week 4, Week 6, Week 8	Response was defined as a reduction in the PANSS total score from baseline by 20% or greater, calculated by first subtracting 30 (the PANSS minimum possible total score). Response rate is the percentage of participants with a response.
Primary	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score	Baseline, Week 2, Week 4, Week 6, Week 8	AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28. A negative change from baseline indicates an improvement.
Primary	Number of Treatment-emergent Adverse Events During Randomized Trial	From Baseline up to Week 8	Adverse event: any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Serious adverse event (SAE): significant hazard, contraindication, side effect, or precaution, which fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial	From Baseline up to Week 8	All participants in the randomized trial.	side effect events	NUMBER
PRIMARY	Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	Baseline, Week 2, Week 4, Week 6, Week 8	All study participants with available data at each time point.	units on a scale	MEAN
PRIMARY	Change From Baseline in the Barnes Akathisia Scale (BAS)	Baseline, Week 2, Week 4, Week 6, Week 8	All participants who had available data at each time point.	units on a scale	MEAN
PRIMARY	Number of Participants With High and Low Levels in Serum Prolactin Concentration	Baseline, Week 8	All participants with available data at each time point.	participants	NUMBER
PRIMARY	Vital Signs: Systolic and Diastolic Blood Pressure Levels	Baseline, Week 1, Week 2, Week 4, Week 6, Week 8	All participants with available data at each time point.	mmHg	MEAN
PRIMARY	Electrocardiogram (EKG): Number of Participants With an Increase From Baseline to Corrected QT (QTc) Interval >/= 500 Milliseconds (Msec)	6 hours after dosing of Weeks 1, 2 and 8	All participants with available data at each time point.	participants	NUMBER
PRIMARY	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score	Baseline, Week 2, Week 4, Week 6, Week 8	All participants with available data at each time point.	units on a scale	MEAN
PRIMARY	Percentage of Participants With Response	Baseline, Week 2, Week 4, Week 6, Week 8	All participants with available data at each time point	percentage of participants	NUMBER
PRIMARY	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score	Baseline, Week 2, Week 4, Week 6, Week 8	All participants with available data at each time point.	units on a scale	MEAN
PRIMARY	Number of Treatment-emergent Adverse Events During Randomized Trial	From Baseline up to Week 8	Safety population includes all participants who received at least one dose of study medication.	adverse events	NUMBER

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group138

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial	High-Dose Ziprasidone		633		side effect events
Number of Events Recorded Based on Ziprasidone Side Effects Checklist During Randomized Trial	Placebo, Standard Treatment Ziprasidone		588		side effect events
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	High-Dose Ziprasidone	Baseline	1.5	Standard Deviation 2.0	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	Placebo, Standard Treatment Ziprasidone	Baseline	1.5	Standard Deviation 2.7	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	High-Dose Ziprasidone	Change from Baseline at Week 2	0.44	Standard Deviation 1.93	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	Placebo, Standard Treatment Ziprasidone	Change from Baseline at Week 2	-0.65	Standard Deviation 2.21	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	High-Dose Ziprasidone	Change from Baseline at Week 4	0.46	Standard Deviation 2.08	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	Placebo, Standard Treatment Ziprasidone	Change from Baseline at Week 4	-0.35	Standard Deviation 2.12	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	High-Dose Ziprasidone	Change from Baseline at Week 6	0.59	Standard Deviation 3.06	units on a scale
Change From Baseline in Simpson Angus Scale for Extrapyramidal Symptoms (SAS)	Placebo, Standard Treatment Ziprasidone	Change from Baseline at Week 6	-0.09	Standard Deviation 2.41	units on a scale

1 to 10 of 138Source ClinicalTrials.gov

See all 138 results by group

Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Signed Informed Consent/Open-Label	STARTED	Standard Treatment Ziprasidone	131
Signed Informed Consent/Open-Label	STARTED	High-Dose Ziprasidone	0
Signed Informed Consent/Open-Label	STARTED	Placebo, Standard Treatment Ziprasidone	0
Signed Informed Consent/Open-Label	COMPLETED	Standard Treatment Ziprasidone	103
Signed Informed Consent/Open-Label	COMPLETED	High-Dose Ziprasidone	0
Signed Informed Consent/Open-Label	COMPLETED	Placebo, Standard Treatment Ziprasidone	0
Signed Informed Consent/Open-Label	NOT COMPLETED	Standard Treatment Ziprasidone	28
Signed Informed Consent/Open-Label	NOT COMPLETED	High-Dose Ziprasidone	0
Signed Informed Consent/Open-Label	NOT COMPLETED	Placebo, Standard Treatment Ziprasidone	0
Screening Phase	STARTED	Standard Treatment Ziprasidone	103

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events116

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hypertension	Vascular disorders	Standard Treatment Ziprasidone Open-label Phase	12	131
other	Hypertension	Vascular disorders	Standard Treatment Ziprasidone Screening Phase	5	103
other	Hypertension	Vascular disorders	High-Dose Ziprasidone Randomized Trial	7	38
other	Hypertension	Vascular disorders	Placebo, Standard Treatment Ziprasidone Randomized Trial	5	37
other	Constipation	Gastrointestinal disorders	Standard Treatment Ziprasidone Open-label Phase	4	131
other	Constipation	Gastrointestinal disorders	Standard Treatment Ziprasidone Screening Phase	1	103
other	Constipation	Gastrointestinal disorders	High-Dose Ziprasidone Randomized Trial	1	38
other	Constipation	Gastrointestinal disorders	Placebo, Standard Treatment Ziprasidone Randomized Trial	4	37
other	Tachycardia	Cardiac disorders	Standard Treatment Ziprasidone Open-label Phase	3	131
other	Tachycardia	Cardiac disorders	Standard Treatment Ziprasidone Screening Phase	3	103

1 to 10 of 116Source ClinicalTrials.gov

See all 116 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Treatment Ziprasidone Open-label Phase
Total, all-cause mortality	Standard Treatment Ziprasidone Screening Phase
Total, all-cause mortality	High-Dose Ziprasidone Randomized Trial
Total, all-cause mortality	Placebo, Standard Treatment Ziprasidone Randomized Trial
Total, other adverse events	Standard Treatment Ziprasidone Open-label Phase	37	131
Total, other adverse events	Standard Treatment Ziprasidone Screening Phase	28	103
Total, other adverse events	High-Dose Ziprasidone Randomized Trial	23	38
Total, other adverse events	Placebo, Standard Treatment Ziprasidone Randomized Trial	19	37
Total, serious adverse events	Standard Treatment Ziprasidone Open-label Phase	4	131
Total, serious adverse events	Standard Treatment Ziprasidone Screening Phase	2	103

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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