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Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

Primary Purpose

Bipolar Disorder

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

placebo oral capsules

ziprasidone oral capsules

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Harmonex Neuroscience Research, Inc.
Woodland International Research Group Inc.
Woodland International Research Group, LLC
California Pharmaceutical Research Institute
NRC Research Institute
Asclepes Research Centers
University of California Davis Medical Center MIND Institute
Elite Clinical Trials, Incorporated
Children's National Health System
Da Vinci Research Institute Inc
Sarkis Clinical Trials
Medical Research Group of Central Florida
APG Research LLC
Atlanta Center for Medical Research
Inova Clinical Trials and Research Centre
Attalla Consultants, LLC dba Institute for Behavioral Medicine
Sleep and Behavior Medicine Institute
Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit
Kennedy Krieger Institute Inpatient Clinic
Kennedy Krieger Institute Outpatient Clinic
Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit
Johns Hopkins Hospital Pediatric Clinical Research Unit
Charlotte R. Bloomberg Children's Center
Johns Hopkins Hospital Investigational Drug Services
Clinical Research Integrity(CRI) Lifetree, LLC
Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
The Zucker Hillside Hospital Northwell Health
Manhattan Behavioral Medicine
Finger Lakes Clinical Research
University of Cincinnati
University Hospitals Cleveland Medical Center
The Ohio State University
Sooner Clinical Research
Cutting Edge Research Group
Paradigm Research Professionals, LLC
UT Health Science Center at Houston (UTHSC-H)
AIM Trials
Research Across America
Family Psychiatry Of The Woodlands
Fontaine Medical Laboratories
Northridge Medical Plaza
University of Virginia Center for Psychopharmacology Research in Youth
UVA Child & Family Psychiatry Clinic
Clinical Research Partners, LLC
Carilion Medical Center
Eastside Therapeutic Resource dba Core Clinical Research
Communal Non profit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council"
Communal Nonprofit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council
Communal Nonprofit Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa
Municipal Institution "Vinnytsya Regional Psychoneurologycal Hospital Named After O.I. Yushenko"

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

ziprasidone

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4

YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) 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 was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania.

Secondary Outcome Measures

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 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), higher scores indicated more severity of illness.

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3

Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4

CGI-I: 7-point clinician rated scale which rates the participant's improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement.

Full Information

NCT ID

NCT02075047

First Posted

February 27, 2014

Last Updated

June 15, 2021

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02075047

Brief Title

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

Official Title

A PHASE 3, MULTICENTER, FOUR-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP EFFICACY AND SAFETY TRIAL OF FLEXIBLE DOSES OF ORAL ZIPRASIDONE IN CHILDREN AND ADOLESCENTS WITH BIPOLAR I DISORDER (CURRENT OR MOST RECENT EPISODE MANIC)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Terminated

Why Stopped

Based on recent input from FDA, the pre-specified final analysis will be performed at the current enrollment using a re-estimation of the sample size.

Study Start Date

May 23, 2014 (Actual)

Primary Completion Date

April 11, 2020 (Actual)

Study Completion Date

May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

ziprasidone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

placebo oral capsules

Intervention Description

Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.

Intervention Type

Drug

Intervention Name(s)

ziprasidone oral capsules

Intervention Description

Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.

Primary Outcome Measure Information:

Title

Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4

Description

Time Frame

Baseline, Week 4

Secondary Outcome Measure Information:

Title

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4

Description

Time Frame

Baseline, Week 1, 2, 3, 4

Title

Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3

Description

Time Frame

Baseline, Week 1, 2, 3

Title

Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4

Description

Time Frame

Baseline, Week 1, 2, 3, 4

Other Pre-specified Outcome Measures:

Title

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.

Time Frame

Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks)

Title

Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS)

Description

C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods [not plan], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). Rows according to C-CASA categories at specified time points are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm.

Time Frame

Screening (2 Weeks prior to Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)

Title

Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures

Description

Concomitant medications or treatments were those prescription and over-the-counter drugs and supplements or non drug treatment/procedures other than the study medication.

Time Frame

Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

Title

Number of Participants With Laboratory Abnormalities

Description

Criteria: Hematology-hemoglobin(Hg),hematocrit,erythrocytes(ery)<0.8*LLN,ery mean corpuscular volume <0.9*LLN>1.1*ULN,platelets<0.5*LLN>1.75*ULN,leukocytes(leu)<0.6*LLN>1.5*ULN,lymphocytes(lym),lym/leu,neutrophils(neu),neu/leu<0.8*LLN>1.2*ULN,basophils (bas),bas/leu, eosinophils(eos), eos/leu, monocytes(mon),mon/leu>1.2*ULN; Clinical chemistry bilirubin: total, direct, indirect>1.5*ULN, aspartate aminotransferase,alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase,alkaline phosphatase>3.0*ULN,protein,albumin<0.8*LLN>1.2*ULN,blood urea nitrogen,creatinine>1.3*ULN, urate>1.2*ULN,HDL<0.8*LLN;LDL>1.2*ULN cholesterol(CH),sodium<0.95*LLN>1.05*ULN,potassium, chloride,calcium,magnesium,bicarbonate<0.9*LLLN>1.1*ULN,phosphate,free thyroxine,thyroid stimulating hormone<0.8*LLN>1.2*ULN,prolactin>1.1*ULN,glucose<0.6*LLN>1.5*ULN,HgA1C,CH, triglycerides>1.3*ULN,creatine kinase>2.0*ULN; Urinalysis-specific gravity<1.003>1.030,pH<4.5 >8,urine glucose, protein, Hg, ketones:>=1.

Time Frame

Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

Title

Number of Participants With Physical Examination Abnormalities

Description

Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia [if medically indicated], extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion.

Time Frame

Screening (2 Weeks prior to Day 1) up to Week 4

Title

Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit

Description

Change from baseline in sitting and standing systolic blood pressure and diastolic blood pressure in millimeter of mercury (mmHg) was reported.

Time Frame

Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)

Title

Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit

Description

Change from baseline pulse rate in (beats per minute) was reported in sitting and standing positions.

Time Frame

Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9)

Title

Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit

Description

Change from baseline in height and waist circumference in centimeter (cm) was reported.

Time Frame

Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

Title

Change From Baseline in Body Weight at Week 4 and Early Termination Visit

Description

Change from baseline in body weight in kilogram (kg) was reported.

Time Frame

Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

Title

Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit

Description

Change from baseline in BMI in kilogram per meter square (kg/m^2) was reported.

Time Frame

Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

Title

Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit

Description

BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.

Time Frame

Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4)

Title

Number of Participants With Pre-defined Categories of Electrocardiogram (ECG) Findings

Description

Pre-defined categories for ECG were: heart rate intervals - QT interval corrected using the Fridericia's formula (QTCF) value greater than or equal to (>=450) millisecond (msec), >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, QT interval corrected using the Bazett's correction (QTCB) value >=450 msec, >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, PR value >=25 percentage increase, QRS value >=25 percentage increase, QT value >=25 percentage increase, Respiratory rate (RR) value >=25 percentage increase, and Heart rate (HR) value >=25 percentage increase. Rows according to ECG pre-defined categories are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm.

Time Frame

Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks)

Title

Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit

Description

CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (maximum impairment). Higher scores indicated greater impairment. Total score calculated as sum of the 17 items ranged from 17 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment.

Time Frame

Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4)

Title

Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4

Description

SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total SARS score is sum of all individual item scores, and ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected.

Time Frame

Baseline, Week 1, 2, 3, 4

Title

Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4

Description

BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. First 3 items (objective, subjective, and distress related to restlessness) were rated on a 4-point scale with range 0 (no symptoms) to 3 (maximum severity of symptoms). Item 4, global clinical assessment of akathisia subscale, was rated on a 6-point scale, and ranged from 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity.

Time Frame

Baseline, Week 1, 2, 3, 4

Title

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4

Description

AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in participants, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 12 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster score, giving a score range of 0 (none) to 28 (maximum severity), higher score indicates greater severity.

Time Frame

Baseline, Week 1, 2, 3, 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Harmonex Neuroscience Research, Inc.

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Facility Name

Woodland International Research Group Inc.

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

Woodland International Research Group, LLC

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72211

Country

United States

Facility Name

California Pharmaceutical Research Institute

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

NRC Research Institute

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Asclepes Research Centers

City

Panorama City

State/Province

California

ZIP/Postal Code

91402

Country

United States

Facility Name

University of California Davis Medical Center MIND Institute

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Elite Clinical Trials, Incorporated

City

Wildomar

State/Province

California

ZIP/Postal Code

92595

Country

United States

Facility Name

Children's National Health System

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Da Vinci Research Institute Inc

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33487

Country

United States

Facility Name

Sarkis Clinical Trials

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Medical Research Group of Central Florida

City

Orange City

State/Province

Florida

ZIP/Postal Code

32763

Country

United States

Facility Name

APG Research LLC

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Inova Clinical Trials and Research Centre

City

Fayetteville

State/Province

Georgia

ZIP/Postal Code

30214

Country

United States

Facility Name

Attalla Consultants, LLC dba Institute for Behavioral Medicine

City

Smyrna

State/Province

Georgia

ZIP/Postal Code

30082-2629

Country

United States

Facility Name

Sleep and Behavior Medicine Institute

City

Vernon Hills

State/Province

Illinois

ZIP/Postal Code

60061

Country

United States

Facility Name

Hugo W. Moser Research Institute at Kennedy Krieger Institute Clinical Trials Unit

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Kennedy Krieger Institute Inpatient Clinic

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Kennedy Krieger Institute Outpatient Clinic

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Psychiatric Mental Health Program at Kennedy Krieger Institute Clinical Trials Unit

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205

Country

United States

Facility Name

Johns Hopkins Hospital Pediatric Clinical Research Unit

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Charlotte R. Bloomberg Children's Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Johns Hopkins Hospital Investigational Drug Services

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Clinical Research Integrity(CRI) Lifetree, LLC

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

The Zucker Hillside Hospital Northwell Health

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

Facility Name

Manhattan Behavioral Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10022

Country

United States

Facility Name

Finger Lakes Clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

University Hospitals Cleveland Medical Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Sooner Clinical Research

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Cutting Edge Research Group

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73116

Country

United States

Facility Name

Paradigm Research Professionals, LLC

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73118

Country

United States

Facility Name

UT Health Science Center at Houston (UTHSC-H)

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

AIM Trials

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Research Across America

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Family Psychiatry Of The Woodlands

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77381

Country

United States

Facility Name

Fontaine Medical Laboratories

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Northridge Medical Plaza

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

University of Virginia Center for Psychopharmacology Research in Youth

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

UVA Child & Family Psychiatry Clinic

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Clinical Research Partners, LLC

City

Petersburg

State/Province

Virginia

ZIP/Postal Code

23805

Country

United States

Facility Name

Carilion Medical Center

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

Eastside Therapeutic Resource dba Core Clinical Research

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Facility Name

Communal Non profit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council"

City

Dnipro

ZIP/Postal Code

49027

Country

Ukraine

Facility Name

Communal Nonprofit Enterprise "City Children Clinical Hospital #5 of Dnipro Regional Council

City

Dnipro

ZIP/Postal Code

49101

Country

Ukraine

Facility Name

Communal Nonprofit Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa

City

Odesa

ZIP/Postal Code

65006

Country

Ukraine

Facility Name

Municipal Institution "Vinnytsya Regional Psychoneurologycal Hospital Named After O.I. Yushenko"

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

35394365

Citation

Findling RL, Atkinson S, Bachinsky M, Raiter Y, Abreu P, Ianos C, Chappell P. Efficacy, Safety, and Tolerability of Flexibly Dosed Ziprasidone in Children and Adolescents with Mania in Bipolar I Disorder: A Randomized Placebo-Controlled Replication Study. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):143-152. doi: 10.1089/cap.2021.0121. Epub 2022 Apr 7.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281198&StudyName=Efficacy%20and%20Safety%20Trial%20of%20Flexible%20Doses%20of%20Oral%20Ziprasidone%20in%20Children%20and%20Adolescents%20with%20Bipolar%20I%20Disorder%20

Description

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Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

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