Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Schizophrenia, Schizophrenia, Major Depression Disorder (MDD), Psychiatric, Psychiatric, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 13 - 17 |
| Updated: | 1/14/2017 |
| Start Date: | May 2006 |
| End Date: | May 2009 |
Open-label Feasibility Study for the Treatment of Psychotic Adolescents With Ziprasidone in the Inpatient and Day Hospital Settings
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.
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.
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.
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.
We found this trial at
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