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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ziprasidone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | subjects will use ziprasidone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain and Other Side Effects | couple of months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence A Maayan, MD | NYSPI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYSPI | New York | New York | 10032 | United States |
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P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone | Ziprasidone: subjects will use ziprasidone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone | Ziprasidone: subjects will use ziprasidone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Gain and Other Side Effects | P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented. | Posted | couple of months |
|
|
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P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone | Ziprasidone: subjects will use ziprasidone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Sherman | New York State Psychiatric Institute | (646) 774-7158 | lsherma@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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|
| Age, Continuous |
| Gender |
|
| Region of Enrollment | participants |
|
| 0 |
| 0 |
| 0 |
| 0 |
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