Please select the eligibility criteria that correspond to the clinical trial below.
Title: Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
Brief Summary: The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.


Options:
A: Inclusion Criteria:

* schizophrenia
* CGI \>=4
* washout of antipsychotics at least 3-5 days
* written informed consents

Exclusion Criteria:

* History of serious adverse events to sulpiride or amisulpride
* History of neuroleptic malignant syndrome or tardive dyskinesia to antipsychotics
* treatment-resistant schizophrenia
* long-acting antipsychotics in the past 3 months
* comorbid with substance abuse/dependence
* female subjects with pregnancy
* severe physical illness
B: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV criteria
* Any schizoaffective disorder or subtype
* Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)
* Currently taking clozapine
* Score of four or higher on two or more items from the positive symptom subscale of the PANSS
* Score of 4 or greater on the Clinical Global Impression (CGI) scale
* Clozapine plasma level greater than 378 µg/ml
* Stable dose of clozapine demonstrated to have been associated with a clozapine plasma level greater than 378 µg/ml for at least eight weeks
* Able to read at an 8th grade level or above

Exclusion Criteria:

* History of unstable coronary artery disease
* Congestive heart failure
* History of long Q-T syndrome
* History of cardiac arrhythmia
* History of cardiac conduction delay
* Baseline QT correction score greater than 0.425 seconds
* Liver disease
* History of stroke
* History of Neuroleptic Malignant Syndrome
* Hypokalemia
* Hypocalcemia
* Current blindness, deafness, language difficulties, or any other disability which may prevent participation or cooperation in the study
* Current suicidal or homicidal thoughts
* Currently abusing psychoactive substances
* Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not criteria for exclusion)
C: Inclusion Criteria:

* Patients with schizophrenia and schizoaffective disorder according to International Classification of Diseases (ICD-10);
* age 18-65;
* Positive and Negative Symptom Scale Total-Score ≥ 70 and two items of the positive symptom subscale ≥4.
* voluntary treatment after written informed consent
* legal capacity
* exclusion of pregnancy by laboratory test (Beta HCG)

Exclusion Criteria:

* participation in other interventional studies with drugs or medical devices
* first episode patients
* physical disease that might have effects on the conduct or evaluation of the trial
* contraindications to medication according to experts information
* oversensitivity to active substance or other component of the drugs used
* known clozapine resistance
* suicidal ideation
* pregnancy or lactation
* which of pregnancy or absence save contraception
* dependency to sponsor or investigator
* institutionalization through judicial or regulatory order
* oversensitivity to placebo (mannite/aerosil)
D: Inclusion Criteria include:

1. Male and female subjects between the ages of 18 to 65 years, inclusive.
2. Subjects who are on stable, oral, chronic (\>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.

Exclusion Criteria include:

1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded.
2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded.
3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded.
4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded.
5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.

Answer: D