Bipolar DisorderPhase 3NCT00265330

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

A Phase 3 study testing Ziprasidone oral capsules in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed) Read more about this study

Who is it for?: Ages 10 to 17 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Ziprasidone oral capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 169 participants
Where: 41 sitesUnited States
Study dates: Mar 2006to Jan 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Who cannot join

Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

United States41 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Arlington, Texas, 76011
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Charleston, South Carolina, 29405
Pfizer Investigational Site
Cincinnati, Ohio, 45224
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cincinnati, Ohio, 45267-0559
Pfizer Investigational Site
Cleveland, Ohio, 44106-5080
Pfizer Investigational Site
Clinton Township, Michigan, 48038
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Fort Lauderdale, Florida, 33301
Pfizer Investigational Site
Honolulu, Hawaii, 96826
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Lexington, Kentucky, 40509
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Meridian, Mississippi, 39301
Pfizer Investigational Site
Milwaukee, Wisconsin, 53226
Pfizer Investigational Site
North Miami, Florida, 33161
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73101
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73107
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73116
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Orange City, Florida, 32763
Pfizer Investigational Site
Owensboro, Kentucky, 42301
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Rochester, New York, 14618
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Scottsdale, Arizona, 85251
Pfizer Investigational Site
Shreveport, Louisiana, 71103
Pfizer Investigational Site
Spokane, Washington, 99204
Pfizer Investigational Site
St Louis, Missouri, 63044-2588
Pfizer Investigational Site
Tavares, Florida, 32778
Pfizer Investigational Site
Terre Haute, Indiana, 47802
Pfizer Investigational Site
Tulsa, Oklahoma, 74114
Pfizer Investigational Site
West Allis, Wisconsin, 53227

Other trials in United States

About this study

Official title: 26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

Conditions: Bipolar Disorder
Being tested: Ziprasidone oral capsules
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ziprasidone oral capsulesDrug
Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .

Study groups in NCT00265330
Study group	Role	What they receive
Open	Experimental	Not described Receives: Drug: Ziprasidone oral capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Young Mania Rating Scale (YMRS) Total Score Change From Baseline
YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
Measured: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)
Clinical Global Impression of Severity (CGI-S) Change From Baseline
CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).
Measured: baseline and 26 Weeks; 26 Weeks LOCF
Incidence of Lab Abnormalities
number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.
Measured: Week 26
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
Mean Change: lab value at observation minus lab value at baseline.
Measured: Week 6, Week 26
Change in Hormones
Mean Change: lab value at observation minus lab value at baseline
Measured: Week 6, Week 26
Mean Change From Baseline in Supine Systolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Measured: Week 1 through Week 26
Mean Change From Baseline in Supine Diastolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Measured: Week 1 through Week 26
Mean Change From Baseline in Supine Pulse Rates
Mean Change: vital sign value at observation minus vital sign value at baseline
Measured: Week 1 through Week 26
Mean Change From Baseline in Standing Systolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Measured: Week 1 through Week 26
Mean Change From Baseline in Standing Diastolic Blood Pressure
Mean Change: vital sign value at observation minus vital sign value at baseline
Measured: Week 1 through Week 26
Mean Change From Baseline in Standing Pulse Rates
Mean Change: vital sign value at observation minus vital sign value at baseline
Measured: Week 1 through Week 26
Mean Change From Baseline for Body Weight
Mean change; body weight value at observation minus body weight value at baseline.
Measured: Week 6, Week 26
Mean Change From Baseline for Body Mass Index (BMI) Z-Score
mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Measured: Week 6, 26, early termination
Body Mass Index (BMI) Z-score Frequency
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Measured: Week 6
Body Mass Index (BMI) Z-score Frequency
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Measured: Week 26
Mean Change From Baseline for QTcF Intervals
QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.
Measured: Baseline to Week 26 (end of study)
Frequency of Largest Categorical Increases in QTcF for Males
QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Measured: Week 26 (end of study)
Frequency of Largest Categorical Increases in QTcF for Females
QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Measured: Week 26 (end of study)
Frequency of Largest Categorical Increases in QTcF - All Subjects
QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Measured: Week 26 (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Jan 2008

First posted14 Dec 2005 (estimated)
Study startMar 2006
Primary completionJan 2008
Study completionJan 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 169 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00265330
Sponsor's protocol ID: A1281133
Status last verified: Mar 2021
First submitted: 12 Dec 2005
Last updated: 25 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.
PubMed 24111980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
ClinicalTrials.gov ID: NCT00265330
Acronym / sponsor ID: A1281133
Conditions: Bipolar Disorder
Keywords: Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 169 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Mar 2006
Primary completion: Jan 2008 (actual)
Study completion: Jan 2008 (actual)
First posted: 14 Dec 2005 (estimated)
Results: Posted 3 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Open	Experimental	Drug: Ziprasidone oral capsules

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Participation in double-blind treatment study A1281132, meeting specific criteria of duration and safety

Key exclusion criteria (1 listed)

Imminent risk of suicide or homicide, as judged by the site investigator;serious adverse event related to study medication in study A1281132; significant prolongation of QT interval in study A1281132.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ziprasidone oral capsulesStudy medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .	Drug	Open

Primary outcome

Young Mania Rating Scale (YMRS) Total Score Change From Baseline
Time frame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)
YMRS: 11-item instrument with scales 0 (normal) to 4 (highest abnormal)for 7 items and 0 (normal) to 8 (highest abnormal) for 4 items. Total possible 0 - 60. Baseline is from parent study A1281132.
Clinical Global Impression of Severity (CGI-S) Change From Baseline
Time frame: baseline and 26 Weeks; 26 Weeks LOCF
CGI-S Scale:standardized assessment tool to rate severity of subject's illness; assesses investigator's impression of subject's current illness state. Change: score at observation minus score at baseline. Score: 1 (not ill at all) to 7 (among most extremely ill). Baseline = last available observation from parent double-blind study(A1281132).
Incidence of Lab Abnormalities
Time frame: Week 26
number of subjects with an abnormal lab value for those parameters with 5% or greater incidence of abnormality.
Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol
Time frame: Week 6, Week 26
Mean Change: lab value at observation minus lab value at baseline.
Change in Hormones
Time frame: Week 6, Week 26
Mean Change: lab value at observation minus lab value at baseline
Mean Change From Baseline in Supine Systolic Blood Pressure
Time frame: Week 1 through Week 26
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Supine Diastolic Blood Pressure
Time frame: Week 1 through Week 26
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Supine Pulse Rates
Time frame: Week 1 through Week 26
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Systolic Blood Pressure
Time frame: Week 1 through Week 26
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Diastolic Blood Pressure
Time frame: Week 1 through Week 26
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline in Standing Pulse Rates
Time frame: Week 1 through Week 26
Mean Change: vital sign value at observation minus vital sign value at baseline
Mean Change From Baseline for Body Weight
Time frame: Week 6, Week 26
Mean change; body weight value at observation minus body weight value at baseline.
Mean Change From Baseline for Body Mass Index (BMI) Z-Score
Time frame: Week 6, 26, early termination
mean change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Body Mass Index (BMI) Z-score Frequency
Time frame: Week 6
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Body Mass Index (BMI) Z-score Frequency
Time frame: Week 26
change in body weight BMI -Z score calculated by subtracting median reference value of the population from observed value and dividing by standard deviation of reference population (kg/m squared). 0=no change
Mean Change From Baseline for QTcF Intervals
Time frame: Baseline to Week 26 (end of study)
QT intervals (observed in an electrocardiogram)corrected using Fridericia's formula (QTcF). Mean change: mean change of observation minus baseline. Baseline: last available observation in the parent double-blind study.
Frequency of Largest Categorical Increases in QTcF for Males
Time frame: Week 26 (end of study)
QT intervals (observed in an electrocardiogram) corrected with Fridericia's Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Frequency of Largest Categorical Increases in QTcF for Females
Time frame: Week 26 (end of study)
QT interval (observed in an electrocardiogram) corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.
Frequency of Largest Categorical Increases in QTcF - All Subjects
Time frame: Week 26 (end of study)
QT intervals (observed in an electrocardiogram)corrected using Fridericia Formula (QTcF). Number of subjects with corresponding categorical increase in QTcF.

Results and safety

Results posted to the registry on 3 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ziprasidone	162	67

Primary outcome: Young Mania Rating Scale (YMRS) Total Score Change From Baseline

Time frame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF). Mean (Standard Deviation). Unit: score on scale

Measure	Ziprasidone n = 162
Week 2 (n=153)	-3.8 (9.0)
Week 6 (n=122)	-4.0 (9.1)
Week 18 (n=76)	-6.3 (12.7)
Week 26 (n=69)	-6.1 (11.6)
Early Termination (n=59)	1.5 (11.3)
Week 26-LOCF (n=153)	-3.3 (10.7)

Population analysed: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)

Primary outcome: Clinical Global Impression of Severity (CGI-S) Change From Baseline

Time frame: baseline and 26 Weeks; 26 Weeks LOCF. Mean (Standard Deviation). Unit: score on scale

Measure	Ziprasidone n = 162
Week 1 (n=159)	-0.2 (0.9)
Week 2 (n=150)	-0.5 (1.2)
Week 6 (n=122)	-0.4 (1.1)
Week 10 (n=99)	-0.7 (1.3)
Week 14 (n=85)	-0.7 (1.2)
Week 18 (n=76)	-0.7 (1.5)
Week 22 (n=70)	-0.8 (1.3)
Week 26 (n=69)	-1.1 (1.4)

Population analysed: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n=number subjects with observation)

Primary outcome: Incidence of Lab Abnormalities

Time frame: Week 26. Number. Unit: participants

Measure	Ziprasidone n = 136
Bicarbonate (N=136)	44
Urine blood/Hemoglobin (N=136)	34
Urine ketones (N=136)	32
Testosterone (N=134)	22
Urine specific gravity (N=136)	13
Urine red blood cells (N=136)	13
Monocytes (N=134)	9
Triglycerides (N=136)	10

Population analysed: Total number of subjects with given laboratory test at given visit. Range: N=136-134, with the exception of Insulin (N=115)

Primary outcome: Change in Low-Density Lipoprotein (LDL) Cholesterol and Fasting Cholesterol

Time frame: Week 6, Week 26. Mean (Standard Deviation). Unit: milligram /deciliter (mg/dL)

Measure	Ziprasidone n = 134
LDL cholesterol Week 6 (n=113)	-7.5 (19.7)
LDL cholesterol Week 26 (n=59)	-8.9 (19.5)
LDL cholesterol Early Termination (n=44)	-7.6 (20.1)
Fasting cholesterol Week 6 (n=113)	-7.7 (21.8)
Fasting cholesterol Week 26 (n=59)	-10.3 (22.7)
Fasting cholesterol Early Termination (n=44)	-8.6 (24.9)

Population analysed: The Safety Analysis Set includes all subjects who took at least one dose of study medication in this open-label extension study. (Row: n= total number of subjects with at least 1 observation of the given laboratory test.)

Adverse events

Time frame: Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziprasidone	17 of 162 (10.5%)	123 of 162 (75.9%)	Not reported

Limitations and caveats (from the sponsor): The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24111980Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziprasidone oral capsules in people with Bipolar Disorder, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Young Mania Rating Scale (YMRS) Total Score Change From Baseline (time frame: baseline and 26 Weeks; 26 Weeks Last Observation Carried Forward (LOCF)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00265330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.