Ziprasidone in Pediatric Bipolar Disorder

NCT00622739 | Completed Phase 4 Results DMC

• 1 other identifier: SaxenaZiprasidone
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators hypothesize that slower titration of ziprasidone will result in lesser side effects which will assist in medication compliance as measured by patient report and pill count.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Children; Adolescents; Treatment

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS)

  The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.

  6 weeks of treatment

Secondary Outcomes (5)

• Children's Depression Rating Scale

  6 weeks of treatment

• Clinical Global Impressions-Severity (CGI-S) Scale

  6 weeks of treatment

• SAFTEE (Side Effects Rating Scale)

  6 weeks of treatment

• AIMS (Abnormal Involuntary Movement Scale)

  6 weeks of treatment

• Barnes Akathisia Rating Scale (BARS)

  6 weeks of treatment

Study Arms (2)

ziprasidone rapid dose

ACTIVE COMPARATOR

Rapid Dose Titration Group

Drug: Ziprasidone

ziprasidone slow dose

ACTIVE COMPARATOR

Slow Dose Titration Group

Drug: Ziprasidone

Interventions

Ziprasidone DRUG

Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.

Also known as: Geodon

ziprasidone rapid dose

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Outpatients aged 10-17 years
• Currently meet Diagnostic and Statistical Manual of Mental Disorders IV-Text Revision (DSM-IV-TR) criteria for bipolar disorder, type I, II or Not Otherwise Specified (NOS) as determined by the Schedule for Affective Disorders and Schizophrenia -Present/Lifetime (Kiddie-SADS-PL)
• Experiencing manic, hypomanic or mixed states as determined by clinical diagnosis and Kiddie- Young Mania rating scale (K-YMRS) equal to or more than 14
• General good health as determined by medical history, physical examination, and laboratory evaluations
• Female adolescents, if sexually active, must practice birth control methods approved by the primary investigator
• Ability to swallow tablets
• Subject's parent or guardian must be fully capable of monitoring the subject's disease process and compliance to treatment
• Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from subjects.

You may not qualify if:

• Have a lifetime DSM-IV-TR Axis I disorder diagnosis of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders
• DSM-IV-TR diagnosis of alcohol or substance abuse or dependence within the past 6 months
• Serious or unstable medical or neurological conditions which require concomitant medications
• Judged by the principal investigator (PI) to be acutely suicidal or homicidal, or at imminent risk of injuring self or others or causing significant damage to property-i.e., subject needs to be in an inpatient facility
• Known or suspected intelligence quotient (IQ) less than 70
• Have a DSM-IV-TR diagnosis of anorexia and/or bulimia at the time of screening or within the last six months
• Female who is pregnant or nursing
• 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
• Subjects with a history of significant cardiovascular disease or significant concurrent cardiovascular disease, including uncontrolled hypertension, hypotension, congestive heart failure or congenital heart disease
• Subjects with a history of cardiac arrhythmias, conduction abnormalities or known personal history or corrected QT prolongation (including congenital long QT syndrome)
• Subjects with a known genetic risk for QT syndrome determined by family history in first degree relatives
• Subjects taking any medications known to interact with ziprasidone or subjects taking any medications which have been consistently observed to prolong the QT interval
• Subjects with a clinically significant ECG abnormality at screening
• Subjects with persistent QTc (Fridericia) \* 460 msec at screening
• Screening laboratory values outside the normal range and judged to be clinically significant by the investigator

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Stanley Medical Research Institute: collaborator
• Pfizer: collaborator
• Children's Medical Center Dallas: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Kirti Saxena
• Organization: Baylor College of Medicine

kxsaxen1@texaschildrens.org

832-822-4065

Study Officials

• Kirti Saxena, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 22, 2019
• Results First Posted: July 21, 2014

Record last verified: 2019-09

Locations

US (1)