Trial · NCT00257166

Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

NCT00257166, Phase 3, Completed, Pfizer's Upjohn has merged with Mylan to form Viatris Inc.; results first posted 2013-07-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed). Trials, record NCT00257166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00257166

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Trial

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

Title: Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
NCT number: NCT00257166
Status: Completed
Phases: Phase 3
Enrollment: 238 participants, actual
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions: Bipolar Disorder
Interventions: Ziprasidone oral capsules, placebo oral capsules
First posted: 2005-11-22
Last updated: 2021-03-03
Results first posted: 2013-07-19

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	Baseline, Week 4	YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
Secondary	Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Baseline, Week 1, 2, 3	YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
Secondary	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4	Baseline, Week 1, 2, 3, 4	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).
Secondary	Clinical Global Impression - Improvement (CGI-I) Score	Week 1, 2, 3, 4	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.

Source ClinicalTrials.gov

Outcomes4

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 Young Mania Rating Scale (YMRS) Score at Week 4	Baseline, Week 4	Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (\>=) 1 dose of study medication (ziprasidone or placebo) and had \>=1 post-baseline visit. Here, 'n' signifies those participants who were available for this measure at given time points for each group.	units on a scale	MEAN
SECONDARY	Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Baseline, Week 1, 2, 3	ITT population. 'N' (number of participants analyzed) signifies those participants who were available for this measure. 'n' signifies those participants who were available for this measure at given time points for each group respectively.	units on a scale	MEAN
SECONDARY	Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4	Baseline, Week 1, 2, 3, 4	ITT population. Here, 'n' signifies those participants who were available for this measure at given time points for each group respectively.	units on a scale	MEAN
SECONDARY	Clinical Global Impression - Improvement (CGI-I) Score	Week 1, 2, 3, 4	ITT population. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were available for this measure at given time points for each group respectively.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group28

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 Young Mania Rating Scale (YMRS) Score at Week 4	Ziprasidone	Baseline (n=143,86)	26.2	Standard Deviation 6.6	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	Placebo	Baseline (n=143,86)	27.0	Standard Deviation 6.6	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	Ziprasidone	Change at Week 4 (n=97,51)	-13.8	Standard Deviation 7.8	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	Placebo	Change at Week 4 (n=97,51)	-9.9	Standard Deviation 7.7	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Ziprasidone	Change at Week 1 (n=131,85)	-9.3	Standard Deviation 7.5	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Placebo	Change at Week 1 (n=131,85)	-6.3	Standard Deviation 7.1	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Ziprasidone	Change at Week 2 (n=120,81)	-11.5	Standard Deviation 8.7	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Placebo	Change at Week 2 (n=120,81)	-8.1	Standard Deviation 7.9	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Ziprasidone	Change at Week 3 (n=108,65)	-13.0	Standard Deviation 8.1	units on a scale
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Placebo	Change at Week 3 (n=108,65)	-9.0	Standard Deviation 7.3	units on a scale

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ziprasidone	150
Overall Study	STARTED	Placebo	88
Overall Study	Treated	Ziprasidone	149
Overall Study	Treated	Placebo	88
Overall Study	COMPLETED	Ziprasidone	97
Overall Study	COMPLETED	Placebo	51
Overall Study	NOT COMPLETED	Ziprasidone	53
Overall Study	NOT COMPLETED	Placebo	37

Source ClinicalTrials.gov

Adverse events56

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	Vision blurred	Eye disorders	Ziprasidone	9	149
other	Vision blurred	Eye disorders	Placebo	1	88
other	Abdominal pain upper	Gastrointestinal disorders	Ziprasidone	8	149
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	3	88
other	Nausea	Gastrointestinal disorders	Ziprasidone	21	149
other	Nausea	Gastrointestinal disorders	Placebo	6	88
other	Vomiting	Gastrointestinal disorders	Ziprasidone	12	149
other	Vomiting	Gastrointestinal disorders	Placebo	1	88
other	Fatigue	General disorders	Ziprasidone	23	149
other	Fatigue	General disorders	Placebo	6	88

1 to 10 of 56Source ClinicalTrials.gov

See all 56 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	Placebo
Total, other adverse events	Ziprasidone	128	149
Total, other adverse events	Placebo	42	88
Total, serious adverse events	Ziprasidone	6	149
Total, serious adverse events	Placebo	7	88

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24111980	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 Placebo: 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.

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