Bipolar DisorderPhase 3NCT00257166

Safety and Efficacy 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 50 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 determine if flexibly-dosed ziprasidone is safe and effective for the treatment of 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?: Yes, some participants may receive a placebo
How many people: 238 participants
Where: 50 sitesUnited States
Study dates: Jan 2006to Jul 2007
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

DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Who cannot join

Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation

Trial locations and contacts

50 sites in 1 country.

City, postcode or hospital

50 sites in 1 country

United States50 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Altamonte Springs, Florida, 32701
Pfizer Investigational Site
Arlington, Texas, 76011
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Buffalo, New York, 14215
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
Denver, Colorado, 80218
Pfizer Investigational Site
Des Plaines, Illinois, 60016
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Fort Lauderdale, Florida, 33301
Pfizer Investigational Site
Fort Worth, Texas, 76102
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, California, 92868
Pfizer Investigational Site
Orange City, Florida, 32763
Pfizer Investigational Site
Owensboro, Kentucky, 42301
Pfizer Investigational Site
Pikesville, Maryland, 21208
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
Schaumburg, Illinois, 60194
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
Towson, Maryland, 21204
Pfizer Investigational Site
Towson, Maryland, 21286
Pfizer Investigational Site
Tulsa, Oklahoma, 74114
Pfizer Investigational Site
West Allis, Wisconsin, 53227

Other trials in United States

About this study

Official title: Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Conditions: Bipolar Disorder
Being tested: Ziprasidone oral capsules, placebo oral capsules
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
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.
placebo oral capsulesDrug
Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.

Study groups in NCT00257166
Study group	Role	What they receive
Ziprasidone oral capsules	Experimental	Not described Receives: Drug: Ziprasidone oral capsules
Placebo	Placebo comparator	Not described Receives: Drug: placebo oral capsules

What is being measured

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

Change From Baseline in Young Mania Rating Scale (YMRS) Score at 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.
Measured: Baseline, Week 4

Secondary outcomes (3)

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 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.
Measured: Baseline, Week 1, 2, 3
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 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).
Measured: Baseline, Week 1, 2, 3, 4
Clinical Global Impression - Improvement (CGI-I) Score
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.
Measured: Week 1, 2, 3, 4

Timeline

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

Jan 2006Jul 2007

First posted22 Nov 2005 (estimated)
Study startJan 2006
Primary completionJul 2007
Study completionJul 2007

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00257166
Sponsor's protocol ID: A1281132
Status last verified: Mar 2021
First submitted: 21 Nov 2005
Last updated: 3 Mar 2021
Results posted: Yes, on ClinicalTrials.gov

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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
ClinicalTrials.gov ID: NCT00257166
Acronym / sponsor ID: A1281132
Conditions: Bipolar Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 238 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Jul 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 22 Nov 2005 (estimated)
Results: Posted 19 Jul 2013

Clinical summary

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

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ziprasidone oral capsules	Experimental	Drug: Ziprasidone oral capsules
Placebo	Placebo comparator	Drug: placebo oral capsules

Who may qualify

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

Key inclusion criteria (1 listed)

DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Key exclusion criteria (1 listed)

Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation

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 capsulesOral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.	Drug	Ziprasidone oral capsules
placebo oral capsulesOral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID.	Drug	Placebo

Primary outcome

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4
Time frame: 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.

3 secondary outcomes

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3
Time frame: Baseline, Week 1, 2, 3
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4
Time frame: Baseline, Week 1, 2, 3, 4
Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Week 1, 2, 3, 4

Results and safety

Results posted to the registry on 19 Jul 2013, 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	150	97
Placebo	88	51

Primary outcome: Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: units on a scale

Measure	Ziprasidone n = 143	Placebo n = 86
Baseline (n=143,86)	26.2 (6.6)	27.0 (6.6)
Change at Week 4 (n=97,51)	-13.8 (7.8)	-9.9 (7.7)

Ziprasidone vs Placebo: Least squares (LS) mean difference: -5.22 (95% CI -8.12 to -2.31), p = 0.0005, ANCOVA

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziprasidone	6 of 149 (4%)	128 of 149 (85.9%)	Not reported
Placebo	7 of 88 (8%)	42 of 88 (47.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 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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Safety and Feasibility of DBS for Bipolar Depression
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Compulsive Eating and Brain's Reward System in Different Pathologies
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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

50 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 50 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 3 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 50 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. Some participants in this study may receive a placebo. 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 19 Jul 2013). 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?

Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4 (time frame: Baseline, Week 4). 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 NCT00257166, 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 3 Mar 2021.