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Sponsors and Collaborators: |
New York State Psychiatric Institute Pfizer |
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Information provided by: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00421954 |
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 |
Study Start Date: | May 2006 |
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.
Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lawrence A Maayan, MD | 2125435148 | maayanl@childpsych.columbia.edu |
United States, New York | |
NYSPI | Recruiting |
New York, New York, United States, 10032 | |
Contact: Yair Kramer, BA 212-543-6833 kramery@childpsych.columbia.edu |
Principal Investigator: | Lawrence A Maayan, MD | NYSPI |
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 |
psychosis NOS MDD w/ psychotic features bipolar disorder w. psychotic features |
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 |
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 |