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Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT03768726
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This 26-week open-label extension study is designed to provide information on the safety and tolerability of oral ziprasidone (20-80 mg BID (twice daily) with meals) during long-term administration in children and adolescents with Bipolar I Disorder (current or most recent episode manic).

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Ziprasidone Phase 3

Detailed Description:

Study A1281201 is a 6 month, open label extension study of the ongoing double blind, randomized, placebo controlled study of ziprasidone in pediatric Bipolar Disorder (Study A1281198). Study A1281201 will enroll adolescents aged 10 to 17 years with Bipolar I Disorder who have participated in double blind Study A1281198. In order to be enrolled in this open label extension trial, subjects must have met the enrollment criteria for Study A1281198, and must meet the inclusion and exclusion criteria for Study A1281201 at the extension study Baseline visit (last visit in the double blind study).

The purpose of adding this extension study to the ongoing Geodon pediatric bipolar program is to obtain additional longer term safety data in children and adolescents with Bipolar I disorder treated with ziprasidone.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Subjects would completed A1281198 will be transitioned under double blind conditions to 26 weeks of treatment with flexibly dosed opened label ziprasidone.
Masking: None (Open Label)
Masking Description: Subjects who participate in A1281198 will be transitioned under double blind conditions (during the first two weeks of the study) to 26 weeks of treatment with flexibly dosed opened label ziprasidone.
Primary Purpose: Treatment
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 (Most Recent Episode Manic)
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : April 4, 2021
Estimated Study Completion Date : April 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ziprasidone

All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period.

During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules.

During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.

Drug: Ziprasidone

All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period.

During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules.

During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.





Primary Outcome Measures :
  1. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 1 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  2. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 2 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  3. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 4 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  4. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 6 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  5. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 10 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  6. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 14 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  7. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 18 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  8. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 22 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.

  9. Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline, week 26 ]
    YMRS: an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.


Secondary Outcome Measures :
  1. CGI-S [ Time Frame: Baseline, week 1 ]
    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 patients). Higher score = more affected

  2. CGI-S [ Time Frame: Baseline, week 2 ]
    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 patients). Higher score = more affected

  3. CGI-S [ Time Frame: Baseline, week 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 patients). Higher score = more affected

  4. CGI-S [ Time Frame: Baseline, week 6 ]
    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 patients). Higher score = more affected

  5. CGI-S [ Time Frame: Baseline, week 10 ]
    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 patients). Higher score = more affected

  6. CGI-S [ Time Frame: Baseline, week 14 ]
    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 patients). Higher score = more affected

  7. CGI-S [ Time Frame: Baseline, week 18 ]
    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 patients). Higher score = more affected

  8. CGI-S [ Time Frame: Baseline, week 22 ]
    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 patients). Higher score = more affected

  9. CGI-S [ Time Frame: Baseline, week 26 ]
    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 patients). Higher score = more affected



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Evidence of personally signed and dated informed consent document by the legal representative and an assent document by the subject .
  • Subjects and their legal guardians who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • The subjects must have received investigational product in Study A1281198 and completed at least 3 weeks of double blind treatment before entering this open label extension.
  • In the investigator's opinion, the subject must be likely to benefit from antipsychotic therapy .
  • All fertile male subjects and female subjects of childbearing potential who are sexually active and/or their legal guardians, as appropriate, must agree that a highly effective method of contraception

Exclusion Criteria

  • Any subjects from the preceding double blind trail who experienced a serious adverse event which required study medication to be discontinued and the subject to be withdrawn from the study. Subjects who experienced cardiac arrhythmias, conduction abnormalities, or QTc prolongation (confirmed and persistent Fridericia's correction (QTcF) >480 msec or increase from baseline QTcF >60 msec) during the preceding study.
  • Subjects requiring any medications not allowed by the Concomitant Medication Table 12 (see "Concomitant Treatment(s)").
  • Subjects who require treatment with drugs that are known to consistently prolong the QT interval (see Concomitant Medication Table 12).
  • Subjects who are judged by the investigator as being at imminent risk of suicide.
  • Subjects living in the same home as another study participant or having the same caregiver during the same enrollment period (Such subjects can be enrolled in the study at different times but may not be in the study at the same time).
  • Subjects should be excluded or a risk assessment should be done to verify that it is safe for the subject to participate in the trial if the subject's responses on the C SSRS or other information based on the investigator's judgment indicate:

    • Suicide ideation associated with actual intent and a method or plan such that a positive response ('Yes') is made on items 4 or 5 of the suicidal ideation subscale of the C SSRS; or
    • Any suicide behaviors such that a determination of 'yes' is made to any of the suicide behavior items of the C SSRS.
  • Pregnant female subjects, breastfeeding female subjects.
  • Participation in other studies other than the preceding Study.
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768726


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, Alabama
Harmonex, Inc. Not yet recruiting
Dothan, Alabama, United States, 36303
United States, Arkansas
Woodland International Research Group, LLC Not yet recruiting
Little Rock, Arkansas, United States, 72211
United States, California
CMB Clinical Trials Not yet recruiting
Colton, California, United States, 92324
Elite Clinical Trials, Inc. Not yet recruiting
Wildomar, California, United States, 92595
United States, Florida
Da Vinci Research Institute Inc Not yet recruiting
Boca Raton, Florida, United States, 33487
Sarkis Clinical Trials Not yet recruiting
Gainesville, Florida, United States, 32607
Medical Research Group of Central Florida Recruiting
Orange City, Florida, United States, 32763
APG Research, LLC Not yet recruiting
Orlando, Florida, United States, 32803
IMIC, Inc. Not yet recruiting
Palmetto Bay, Florida, United States, 33157
United States, Georgia
Atlanta Behavioral Research, LLC Not yet recruiting
Atlanta, Georgia, United States, 30338
Inova Clinical Trials and Research Centre Not yet recruiting
Fayetteville, Georgia, United States, 30214
Attalla Consultants, LLC dba Institute for Behavioral Medicine Not yet recruiting
Smyrna, Georgia, United States, 30082-2629
United States, Maryland
Hugo W. Moser Research Institute at Kennedy Krieger Institute (Administrative) Not yet recruiting
Baltimore, Maryland, United States, 21205
KKI Outpatient (Patients Screen) Not yet recruiting
Baltimore, Maryland, United States, 21205
Psychiatric Mental Health Program - Clinical Trials Unit Not yet recruiting
Baltimore, Maryland, United States, 21205
Charlotte R. Bllomberg Children's Center (Administrative) Not yet recruiting
Baltimore, Maryland, United States, 21287
Johns Hopkins Hospital Investigational Drug Service (IP Address) Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, New York
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
United States, Ohio
University of Cinicinnati Recruiting
Cincinnati, Ohio, United States, 45219
The Ohio State University Department of Psychiatry Not yet recruiting
Columbus, Ohio, United States, 43210
Charak Clinical Research Center Not yet recruiting
Garfield Heights, Ohio, United States, 44125
United States, Oklahoma
Cutting Edge Research Group Recruiting
Oklahoma City, Oklahoma, United States, 73116
United States, Texas
AIM Trials, LLC Not yet recruiting
Plano, Texas, United States, 75093
Family Psychiatry of the Woodlands Not yet recruiting
The Woodlands, Texas, United States, 77381
United States, Washington
Eastside Therapeutic Resource Inc dba Core Clinical Research Recruiting
Everett, Washington, United States, 98201
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03768726     History of Changes
Other Study ID Numbers: A1281201
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents