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Open-Label Ziprasidone Study for Psychosis Treatment in Adolescents
This study is currently recruiting participants.
Verified by New York State Psychiatric Institute, January 2007
First Received: January 12, 2007   Last Updated: August 8, 2007   History of Changes
Sponsors and Collaborators: New York State Psychiatric Institute
Pfizer
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00421954
  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 III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

Study Start Date: May 2006
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00421954

Contacts
Contact: Lawrence A Maayan, MD 2125435148 maayanl@childpsych.columbia.edu

Locations
United States, New York
NYSPI Recruiting
New York, New York, United States, 10032
Contact: Yair Kramer, BA     212-543-6833     kramery@childpsych.columbia.edu    
Sponsors and Collaborators
New York State Psychiatric Institute
Pfizer
Investigators
Principal Investigator: Lawrence A Maayan, MD NYSPI
  More Information

No publications provided

Study ID Numbers: IRB 5239
Study First Received: January 12, 2007
Last Updated: August 8, 2007
ClinicalTrials.gov Identifier: NCT00421954     History of Changes
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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Depression
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Antipsychotic Agents
Depressive Disorder
Serotonin
Behavioral Symptoms
Schizophrenia
Affective Disorders, Psychotic
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Psychotic Disorders
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

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

ClinicalTrials.gov processed this record on September 09, 2009