Trial · NCT00723606

A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

NCT00723606, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2010-08-25

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation. Trials, record NCT00723606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723606

On this page

Trial

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

Title: A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
NCT number: NCT00723606
Status: Completed
Phases: Phase 3
Enrollment: 376 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Schizophrenia
Interventions: Intramuscular ziprasidone mesylate, Intramuscular haloperidol
First posted: 2008-07-29
Last updated: 2021-03-03
Results first posted: 2010-08-25

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours	Baseline, 72 hours	BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.
Secondary	BPRS Agitation Subscale Response at 72 Hours	72 hours	The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a \> 30 percent reduction from baseline in BPRS agitation subscale score.
Secondary	Change From Baseline in BPRS Agitation Subscale Score at 72 Hours	Baseline, 72 hours	The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.
Secondary	Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours	72 hours	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Secondary	Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours	Baseline, 72 hours	CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
Secondary	Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours	Baseline, 72 hours	BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake \[normal level of activity\]; 5 = signs of overt \[physical or verbal\] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.

Source ClinicalTrials.gov

Outcomes6

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 Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours	Baseline, 72 hours	Per protocol (PP) population = Full Analysis Set (FAS) subjects (ie, randomized subjects who took at least one dose of study medication) who provided a baseline and 72 hour BPRS total score and did not deviate from the protocol in a significant manner.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	BPRS Agitation Subscale Response at 72 Hours	72 hours	FAS. Missing data were replaced by last observation carried forward (LOCF).	participants	NUMBER
SECONDARY	Change From Baseline in BPRS Agitation Subscale Score at 72 Hours	Baseline, 72 hours	FAS. Missing data were replaced by LOCF.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours	72 hours	FAS. Missing data were replaced by LOCF.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours	Baseline, 72 hours	FAS. Missing data were replaced by LOCF.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours	Baseline, 72 hours	FAS. Missing data were replaced by LOCF.	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group14

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 Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours	Ziprasidone		-17.32	Standard Error 0.692	scores on a scale
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours	Haloperidol		-18.44	Standard Error 0.720	scores on a scale
BPRS Agitation Subscale Response at 72 Hours	Ziprasidone	Response	149		participants
BPRS Agitation Subscale Response at 72 Hours	Haloperidol	Response	155		participants
BPRS Agitation Subscale Response at 72 Hours	Ziprasidone	No Response	39		participants
BPRS Agitation Subscale Response at 72 Hours	Haloperidol	No Response	29		participants
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours	Ziprasidone		-6.97	Standard Error 0.225	scores on a scale
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours	Haloperidol		-7.45	Standard Error 0.228	scores on a scale
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours	Ziprasidone		2.52	Standard Error 0.056	scores on a scale
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours	Haloperidol		2.55	Standard Error 0.057	scores on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ziprasidone	189
Overall Study	STARTED	Haloperidol	187
Overall Study	COMPLETED	Ziprasidone	185
Overall Study	COMPLETED	Haloperidol	180
Overall Study	NOT COMPLETED	Ziprasidone	4
Overall Study	NOT COMPLETED	Haloperidol	7

Source ClinicalTrials.gov

Adverse events22

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	Sinus tachycardia	Cardiac disorders	Ziprasidone	5	189
other	Sinus tachycardia	Cardiac disorders	Haloperidol	2	187
other	Constipation	Gastrointestinal disorders	Ziprasidone	5	189
other	Constipation	Gastrointestinal disorders	Haloperidol	2	187
other	Nausea	Gastrointestinal disorders	Ziprasidone	6	189
other	Nausea	Gastrointestinal disorders	Haloperidol	2	187
other	Aspartate aminotransferase increased	Investigations	Ziprasidone	0	189
other	Aspartate aminotransferase increased	Investigations	Haloperidol	5	187
other	Akathisia	Nervous system disorders	Ziprasidone	6	189
other	Akathisia	Nervous system disorders	Haloperidol	7	187

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ziprasidone
Total, all-cause mortality	Haloperidol
Total, other adverse events	Ziprasidone	36	189
Total, other adverse events	Haloperidol	107	187
Total, serious adverse events	Ziprasidone	0	189
Total, serious adverse events	Haloperidol	0	187

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23422376	DERIVED

Source PubMed

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 comparisons1

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

Comparison
Ziprasidone vs Haloperidol: serious adverse events

Source Trial comparisons

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.

GET https://conductscience.org/api/trials/v1/NCT00723606

GET https://conductscience.org/api/trials/v1/NCT00723606/events?page=2

API reference For AI assistants