Trial · NCT00406315

Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

NCT00406315, Phase 4, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-02-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone. Trials, record NCT00406315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00406315

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Trial

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

Title: Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone
NCT number: NCT00406315
Status: Completed
Phases: Phase 4
Enrollment: 255 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Schizophrenia, Schizoaffective Disorder
Interventions: ziprasidone
First posted: 2006-12-04
Last updated: 2021-03-29
Results first posted: 2010-02-02

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Weight at Week 16	Baseline, Week 16, Week 16 LOCF	Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Secondary	Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16	Baseline, Week 16	Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Secondary	Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16	Baseline, Week 16	HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Secondary	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16	Baseline, Week 16	HbAlc value: Change = value at Week 16 minus value at Baseline.
Secondary	Change From Baseline in Fasting Glucose at Week 16	Baseline, Week 16	Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Secondary	Change From Baseline in Fasting Insulin at Week 16	Baseline, Week 16	Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Secondary	Change From Baseline in Waist and Hip Circumference at Week 16	Baseline, Week 16	Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Secondary	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16	Baseline, Week 16	AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Secondary	Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16	Baseline, Week 16, Week 16 LOCF	PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Secondary	Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16	Baseline, Week 16, Week 16 LOCF	The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Weight at Week 16	Baseline, Week 16, Week 16 LOCF	Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.	kilogram	MEAN
SECONDARY	Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16	Baseline, Week 16	Safety population.	milligram (mg)/deciliter (dL)	MEAN
SECONDARY	Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16	Baseline, Week 16	Safety population.	mg/dL	MEAN
SECONDARY	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16	Baseline, Week 16	Safety population.	percent	MEAN
SECONDARY	Change From Baseline in Fasting Glucose at Week 16	Baseline, Week 16	Safety population.	mg/dL	MEAN
SECONDARY	Change From Baseline in Fasting Insulin at Week 16	Baseline, Week 16	Safety population.	microinternational (mciu)/milliliter(mL)	MEAN
SECONDARY	Change From Baseline in Waist and Hip Circumference at Week 16	Baseline, Week 16	Safety population.	centimeter	MEAN
SECONDARY	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16	Baseline, Week 16	Safety population.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16	Baseline, Week 16, Week 16 LOCF	Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.	scores on a scale	MEAN
SECONDARY	Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16	Baseline, Week 16, Week 16 LOCF	ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.	scores on a scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group40

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Weight at Week 16	Ziprasidone	Week 16 (n=133)	-1.09	Standard Deviation 3.918	kilogram
Change From Baseline in Weight at Week 16	Ziprasidone	Week 16 LOCF (n=231)	-0.73	Standard Deviation 3.725	kilogram
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16	Ziprasidone		-3.0	Standard Deviation 31.14	milligram (mg)/deciliter (dL)
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16	Ziprasidone	HDL (n=128)	-0.2	Standard Deviation 9.32	mg/dL
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16	Ziprasidone	LDL (n=123)	-2.5	Standard Deviation 25.66	mg/dL
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16	Ziprasidone	Triglycerides (n=128)	-1.6	Standard Deviation 84.58	mg/dL
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16	Ziprasidone		0.1	Standard Deviation 0.44	percent
Change From Baseline in Fasting Glucose at Week 16	Ziprasidone		3.0	Standard Deviation 17.84	mg/dL
Change From Baseline in Fasting Insulin at Week 16	Ziprasidone		134.8	Standard Deviation 851.28	microinternational (mciu)/milliliter(mL)
Change From Baseline in Waist and Hip Circumference at Week 16	Ziprasidone	Waist (n=132)	-2.9	Standard Deviation 17.53	centimeter

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ziprasidone	241
Overall Study	COMPLETED	Ziprasidone	100
Overall Study	NOT COMPLETED	Ziprasidone	141

Source ClinicalTrials.gov

Adverse events27

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	Nausea	Gastrointestinal disorders	Ziprasidone	28	241
other	Vomiting	Gastrointestinal disorders	Ziprasidone	16	241
other	Decreased appetite	Metabolism and nutrition disorders	Ziprasidone	12	241
other	Akathisia	Nervous system disorders	Ziprasidone	15	241
other	Dizziness	Nervous system disorders	Ziprasidone	13	241
other	Headache	Nervous system disorders	Ziprasidone	24	241
other	Sedation	Nervous system disorders	Ziprasidone	17	241
other	Somnolence	Nervous system disorders	Ziprasidone	35	241
other	Anxiety	Psychiatric disorders	Ziprasidone	15	241
other	Insomnia	Psychiatric disorders	Ziprasidone	46	241

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziprasidone
Total, other adverse events	Ziprasidone	124	241
Total, serious adverse events	Ziprasidone	22	241

Source ClinicalTrials.gov

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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