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Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

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ClinicalTrials.gov Identifier: NCT00421954
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : January 13, 2017
Last Update Posted : January 13, 2017
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Schizophreniform Disorder Schizoaffective Disorder Psychosis Depressive Disorder, Major Bipolar Disorder Drug: Ziprasidone Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2006
Primary Completion Date : May 2008
Study Completion Date : May 2009

Arm Intervention/treatment
Experimental: Ziprasidone Drug: Ziprasidone
subjects will use ziprasidone

Primary Outcome Measures :
  1. Weight Gain and Other Side Effects [ Time Frame: couple of months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00421954

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

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00421954     History of Changes
Other Study ID Numbers: # 5239
First Posted: January 15, 2007    Key Record Dates
Results First Posted: January 13, 2017
Last Update Posted: January 13, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents