Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial)
Brief Summary: The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.


Options:
A: Inclusion Criteria:

* Diagnosis: DSM IV/DSM IV TR schizophrenia (including disorganized, paranoid, undifferentiated, and catatonic subtypes)
* Capable of providing informed consent
* Duration of illness equal to or greater than one year
* Treated with one or two of the following second generation antipsychotics: risperidone, paliperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole for the previous two months, with no change in dose in the last month.
* Meet the following symptom criteria:

  * Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior, Unusual Thought Content or Conceptual Disorganization item score ≤ 4
  * All Scale for the Assessment of Negative Symptoms global items ≤ 3
  * Simpson-Angus Scale total score ≤ 6
  * Calgary Depression Scale total score ≤ 10
* Meet the following cognitive performance criteria:

  * Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests: i.) Letter-number span (20); ii.) HVLT total (31); and iii.) CPT d-prime (3.47)
  * Able to complete the baseline MCCB validly
  * Raw score ≥6 on the WTAR

Exclusion Criteria:

* Current treatment (within 4 weeks) with conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine
* Current treatment with psychotropic agents known to act at the GABAA receptor, including benzodiazepines; sedative-hypnotics other than trazadone and chloral hydrate; carbamazepine, gabapentin, lamotrigine, and valproic acid
* Current treatment with a drug that inhibits CYP3A4, including: cimetidine; cyclosporine; erythromycin or erythromycin-like drugs (e.g., azithromycin, clarithromycin); diltiazem; fluoxetine, fluovoxamine; itraconazole, ketoconazole or other systemic antifungal agents in the azole class; nefazodone; or induce CYP3A4, including: carbamazepine, modafinil; phenobarbital; phenytoin; rifampin; St. Johns wort; and troglitazone.
* Current treatment with psychotropic agents known to effect cognition: amphetamine; barbiturates; lithium; MAOIs; methylphenidate
* Current treatment with herbal preparations with possible psychotropic effects (e.g., St. Johns wort, kava-kava, Valerian, S-Adenosyl Methionine \[SAMe\])
* Current treatment with systemic steroids
* DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence within the last 6 months
* Presence of PI or greater posterior subcapsular cataracts
* Uveitis with 1+ or greater flare or cells
* Nuclear or cortical cataracts
* History of significant head injury/trauma, as defined by one or more of the following: loss of consciousness (LOC) for more than 1 hour, seizures from the head injury, clear cognitive sequellae of the injury, or cognitive rehabilitation following the injury
* History of clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorders.
* Clinically significant abnormalities in physical examination, ECG, or laboratory assessments
* A positive test for Hepatitis C antibody with concurrent evidence of impaired hepatic function (increased AST or ALT greater than 2 times the upper limit of normal) or positive tests for Hepatitis A antibody IgM fraction or Hepatitis B surface antigen, irrespective of the AST or ALT values.
* Pregnant women or women of child-bearing potential, either not surgically-sterile or using appropriate methods of birth control
* Women who are breast-feeding
* History of severe symptoms of benzodiazepine withdrawal (e.g., history of seizures or delirium associated with withdrawal)
* Received ECT treatment within the last 3 months
* Participated in a clinical trial of any other psychotropic medication within 2 months
B: Inclusion

* 18-65 years old
* DSM-IV diagnosis of schizophrenia
* adequate capacity to consent

Exclusion

* Intolerance or failure to respond to one of the treatments
* Diagnoses of schizoaffective disorder, mental retardation, pervasive developmental disorder, delirium, dementia, amnesia
* First episode of schizophrenia
* Women currently pregnant or breast-feeding
C: Inclusion Criteria:

* meet the DSM-IV criteria for schizophrenia as confirmed by modified SCID

Exclusion Criteria:

* meet the full syndromal criteria for other Axis I disorder
* have taken any depot antipsychotic within 4 weeks before screening
* are taking mood-stabilizing agents
D: Inclusion Criteria:

* A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated types) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening evaluation
* a total PANSS score of 60 to 120 at screening and baseline (pre-treatment) evaluations
* a body mass index (BMI \[weight (kilograms)\]/\[height (meters)\]²) of at least 15.0 kg/m² .

Exclusion Criteria:

* A primary active DSM-IV Axis I diagnosis other than schizophrenia
* a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
* a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
* a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
* a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.

Answer: B