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Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00421954
First received: January 12, 2007
Last updated: July 21, 2011
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Schizophreniform Disorder
Schizoaffective Disorder
Psychosis
Depressive Disorder, Major
Bipolar Disorder
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Feasibility Study for the Treatment of Psychotic Adolescents With Ziprasidone in the Inpatient and Day Hospital Settings

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • weight gain and other side effects [ Time Frame: couple of months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: May 2006
Study Completion Date: May 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ziprasidone
    subjects will use ziprasidone
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.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421954

Locations
United States, New York
NYSPI
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Pfizer
Investigators
Principal Investigator: Lawrence A Maayan, MD NYSPI
  More Information

No publications provided

Responsible Party: Lawrence Maayan, NYSPI
ClinicalTrials.gov Identifier: NCT00421954     History of Changes
Other Study ID Numbers: IRB 5239
Study First Received: January 12, 2007
Last Updated: July 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
psychosis NOS
MDD w/ psychotic features
bipolar disorder w. psychotic features

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Mental Disorders
Psychotic Disorders
Affective Disorders, Psychotic
Behavioral Symptoms
Mood Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014