Open-label Ziprasidone Study for Psychosis Treatment in Adolescents

Bipolar Disorder Clinical Trial

Official title:

Open-label Feasibility Study for the Treatment of Psychotic Adolescents With Ziprasidone in the Inpatient and Day Hospital Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421954
• Other study ID #: # 5239
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2007
• Last updated: January 12, 2017
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: January 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophreniform Disorder

Intervention

Drug:
• Ziprasidone
subjects will use ziprasidone

Locations

Country	Name	City	State
United States	NYSPI	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Gain and Other Side Effects		couple of months