Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

NCT00421954

Last updated date
Study Location
NYSPI
New York, New York, 10032, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophreniform Disorder, Schizoaffective Disorder, Psychosis, Major Depressive Disorder, Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Children who meet DSM-IV criteria for the following psychotic disorders: schizophreniform disorder, schizoaffective disorder, psychosis NOS, major depressive disorder with psychotic features, and bipolar disorder with psychotic features.

2. Children with an IQ of at least 70.

3. Children who are in good physical health.

4. The parent/guardian of the child must be willing to attend all study visits.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Children who are currently receiving an effective treatment without detrimental side
effects.


2. Children who are allergic to Geodon®.


3. Children who have previously failed to respond to an adequate trial of Geodon®.


4. Females who are pregnant or breast-feeding.

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Schizophreniform Disorder, Schizoaffective Disorder, Psychosis, Major Depressive Disorder, Bipolar DisorderOpen-label Ziprasidone Study for Psychosis Treatment in Adolescents
NCT00421954
  1. New York, New York
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Official Title  ICMJE Open-label Feasibility Study for the Treatment of Psychotic Adolescents With Ziprasidone in the Inpatient and Day Hospital Settings
Brief Summary This open-label study will assess the medication Geodon® (Ziprasidone) in pediatric patients, aged 13-17, diagnosed with psychotic disorder. Eligible adolescents will receive Geodon® for 7 weeks and stay at the NYSPI Children's Day Unit (CDU) during the day. If clinically appropriate, they may also stay at the New York State Psychiatric Institute (NYSPI) Schizophrenia Research Unit (SRU) inpatient facility.
Detailed Description

This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders (schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified [NOS], major depressive disorder with psychotic features, and bipolar disorder with psychotic features) in an inpatient and day hospital setting with ziprasidone (Geodon). Ziprasidone is a second-generation antipsychotic (SGA) that is FDA-approved for the treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in adults. It is also used clinically in the treatment of psychotic disorders in children, adolescents and adults. This protocol will help to elucidate the feasibility of studying the treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help facilitate the further study of the treatment of psychosis with novel agents that have a favorable side effect and weight gain profile.

The duration of the study can be up to 7 weeks. Depending on the level of symptom severity patients will be managed on either the Schizophrenia Research Unit (SRU) (GAS<35, CGI-S>5), or the Children's Day Unit (CDU) of the NYSPI. The seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results. Over a period of one to two weeks patients will be titrated up to 120 mg/day (80 mg for patients under 45kg), and, if necessary, cross tapered off of another SGA that had not been working successfully. Subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophreniform Disorder
  • Schizoaffective Disorder
  • Psychosis
  • Depressive Disorder, Major
  • Bipolar Disorder
Intervention  ICMJE Drug: Ziprasidone
subjects will use ziprasidone
Study Arms  ICMJE Experimental: Ziprasidone
Intervention: Drug: Ziprasidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 21, 2011)
8
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children who meet DSM-IV criteria for the following psychotic disorders: schizophreniform disorder, schizoaffective disorder, psychosis NOS, major depressive disorder with psychotic features, and bipolar disorder with psychotic features.
  2. Children with an IQ of at least 70.
  3. Children who are in good physical health.
  4. The parent/guardian of the child must be willing to attend all study visits.

Exclusion Criteria:

  1. Children who are currently receiving an effective treatment without detrimental side effects.
  2. Children who are allergic to Geodon®.
  3. Children who have previously failed to respond to an adequate trial of Geodon®.
  4. Females who are pregnant or breast-feeding.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00421954
Other Study ID Numbers  ICMJE # 5239
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Lawrence A Maayan, MDNYSPI
PRS Account New York State Psychiatric Institute
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP