Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01006551
Eligibility Criteria:
Inclusion Criteria:
* Between 6 and 19 years old, male or female.
* Significant psychotic symptoms defined by a behavior score of at least 4 (moderate) on at least one of the psychotic items of Positive and Negative Symptom Scale (PANSS) at baseline.
* Subjects will meet DSM IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder.
* Subjects will be free of depot antipsychotic medication for at least six months.
* Good physical health.
* The subject gives informed assent for the study and his/her guardian is able and willing to give informed consent.
* Mood stabilizing treatment (i.e., antidepressant, lithium, carbamazepine, valproate) will be permitted during the first eight weeks of the study only if the patient has been treated with the mood stabilizer for at least 30 days. Dosages will remain stable for the first 8 weeks unless change or discontinuation is clinically indicated.
Exclusion Criteria:
* A primary diagnosis of substance abuse or dependence.
* Known endocrinological or neurological conditions, which confound the diagnosis or are a contraindication to treatment with antipsychotics.
* Subjects with a clear history of intolerance or nonresponsiveness to ziprasidone.
* Subjects at serious, short term risk for suicide.
* Subjects who are pregnant or who refuse to practice contraception during the study.
* Subjects with known cardiac conduction problems especially prior QTc prolongation, known genetic risk for QTc prolongation or who are being treated with other agents that prolong the QTc. These agents include the antiarrhythmic agents: dofetilide (Tikosyn), sotalol (Betapace), quinidine (Quinaglute), or Class 1A and III antiarrhythmics; the antipsychotics mesoridazine (Serentil), thioridazine (Mellaril), chlorpromazine (Thorazine), droperidol (Inapsine), pimozide (Orap); the anti-infectives: sparfloxacin (Zagam), gatifloxacin (Tequin), moxifloxacin (Avelox), pentamidine (Pentam); the anti-malarials halofantrine (Halfan), mefloquine (Lariam); and arsenic trioxide (Trisenox), levomethadyl acetate (Orlaam), dolasetron mesylate (Anzemet), probucol (Lorelco-an antilipemic), and tacrolimus (Prograf).
* Subjects with a diagnosis of a pervasive developmental disorder or an autism screening questionnaire score \>15, must have clear hallucinations or delusions.
* Subjects will be excluded if they meet criteria for a current major depressive episode.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
19 Years
Study:
NCT01006551
Study Brief:
Protocol Section:
NCT01006551