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

• Conditions: Bipolar Disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-000606-20-Outside-EU/EEA
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-03
• Last Update Posted: 13 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

1.The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent.
2.The subject (male or female) must be between 10-17 (inclusive) years of age at screening.
3.The subject must have a primary diagnosis of Bipolar I Disorder - Single Manic Episode, Bipolar I Disorder – Most Recent Episode Manic, or Bipolar I Disorder – Most Recent Episode Mixed, as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria and confirmed by the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS).
4.The current symptoms must have been present for at least 7 days prior to Screening.
5.At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score greater than or equal to (?) 17
6.In the investigator’s opinion, the subject must be likely to benefit from therapy with an atypical antipsychotic drug.
7.The subject must have a Body Mass Index (BMI) within the 5th-95th percentile as determined from BMI charts from the Centers for Disease Control.
8.The subject is willing and able to discontinue any medications that are prohibited in this study (see Concomitant Medications table, Section 5.5). Any such medications must be discontinued at least 4 half-lives (or 10 ten days, whichever is less) prior to the administration of double-blinded study medication.
9.Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria:
Are instructed and agree to avoid pregnancy during the study.
Have a negative urine pregnancy test (ß-HCG) at screening and baseline.
Use one of the following birth control methods: a) an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g. Ortho-Evra), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; b) a barrier method of contraception, e.g., condom and/or diaphragm with spermicide while participating in the study, c) abstinence for at least 3 months before the start of the study and intention to abstain from sexual activity during the study period.

Are the trial subjects under 18? yes
Number of subjects for this age range: 236
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects who are clinically stable on treatment regimens that are being well tolerated.
2.Subjects with substance-induced psychotic disorder or whose behavioral disturbance is thought to be due to substance abuse.
3.Subjects with DSM-IV defined psychoactive substance or alcohol abuse/dependence (does not apply to nicotine or caffeine) within the preceding 1 month.
4.Subjects with a rating of 7 on the single Suicidal Ideation item (item #13) from the Child Depression Rating Scale- Revised (CDRS-R), or who are otherwise judged by the investigator as being at imminent risk of suicide.
5.Subjects who are judged by the investigator as being at imminent risk of homicide
6.Subjects with significant mental retardation (i.e. Intelligence quotient [IQ] less than [<] 70) that would interfere with study conduct or with the interpretation of the study assessments.
7.Subjects with autism or pervasive developmental disorder.
8.Subjects with any serious, unstable illness including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic (including controlled or uncontrolled Type I diabetes), immunologic, hematologic, dermatological, oncological, or neurological disease (including any history of seizure or epilepsy).
9.Subjects with a history of syncopal episodes (sudden loss of consciousness with loss of postural tone and not preceded by a pre-syncopal phase) or unexplained loss of consciousness.
10.Subjects with any medical condition or dietary habit that has a significant potential to alter the absorption of the study drug; or subjects taking any medication that may alter drug absorption. (eg anorexia nervosa, bulimia, chronic use of laxatives).
11.Subjects with uncorrected hypothyroidism or hyperthyroidism or whose thyroid function and medication regimen have been stable less than 1 month.
12.Subjects with any screening laboratory value that deviates significantly from the upper or lower limits of the normal reference range. Serum glutamic oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) must be within 2 X and total bilirubin must be within 1.5 X times of the upper limits of the reference range.
13.Subjects with a history of chronic hepatitis, known serologic evidence of acute hepatitis or chronic hepatitis (positive HbsAg), or subjects with known hepatitis C antibodies and elevated Liver function tests (LFTs).
14.Subjects known to be human immunodeficiency virus (HIV) positive.
15.Subjects with clinically significant hypokalemia or hypomagnesemia not corrected and stabilized by the addition of dietary supplements or some other corrective measure prior to Baseline.
16.Subjects with a history of significant cardiovascular disease or significant concurrent cardiovascular disease, including uncontrolled hypertension (sitting diastolic pressure greater than[>]90 millimeters mercury (mm Hg) and/or sitting systolic pressure > 140 mm Hg with or without treatment), hypotension, congestive heart failure, or congenital heart disease.
17.Subjects with a history of cardiac arrhythmias, conduction abnormalities or known personal history of QT prolongation (including congenital long QT syndrome).
18.Subjects with a known genetic risk for prolonged QT syndrome
19.Subjects with a clinically significant electrocardiogram (ECG) abnormality at Screening or Baseline
20.Subjects with persistent QTc (Fridericia) >= 460 msec at Screening or Baseline.
21.Subjects taking any me

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified