Please select the eligibility criteria that correspond to the clinical trial below.
Title: Sertindole Versus Risperidone Safety Outcome Study: a Randomised, Partially-blinded, Parallel-group, Active-controlled, Post-marketing Study
Brief Summary: The purpose of the study is to determine whether there is an increased all-cause mortality in sertindole-treated patients in comparison to patients treated with a well-known antipsychotic (risperidone) when used under normal marketed conditions in the treatment of schizophrenia.


Options:
A: Inclusion Criteria:

* The patient has signed the Informed Consent Form or, if he/she is not able to sign it (according to the ICH GCP guidelines and the Declaration of Helsinki), the patient's legal representative has signed the Informed Consent Form
* The patient has been diagnosed with schizophrenia
* Based on the patient's clinical status, new or change of antipsychotic treatment is indicated
* The patient is at least 18 years of age
* The patient meets the criteria set out in the national SPCs for sertindole and risperidone. For those countries in which sertindole was not marketed, the EU SPC applied

Exclusion Criteria:

* The last treatment taken by the patient was sertindole or risperidone
* The patient has never previously received any antipsychotic drug therapy
* The patient has contraindications to treatment with either sertindole or risperidone
* In addition to sertindole/risperidone, treatment with another antipsychotic is indicated
* The patient is homeless
* The patient has previously been included in one of the two H. Lundbeck A/S post-marketing studies, 99823 or 99824
* The patient is, in the opinion of the investigator, unlikely to comply with the study protocol or unsuitable for any other reason
B: Inclusion Criteria:

* Age 18 to 75
* Meet Diagnostic \& Statistical Manual - 4 (DSM-IV) criteria for schizophrenia, schizoaffective disorder, bipolar disorder, major depression, or another psychotic disorder based on Structured Clinical Interview for the DSM-IV (SCID) interview
* Body Mass Index (BMI) of 28 and over
* On a stable dose of antipsychotic medication; i.e. at least one month with no dose change, and three months from an antipsychotic switch
* Deemed to be symptomatically stable by the clinical staff in the last two months
* Over 7% total body weight increase on antipsychotics for subjects within first year of illness

Exclusion Criteria:

* Meet criteria for current opiate abuse or dependence (confirmed by positive urine drug screen for opiates or, if suspected by study doctor via patient history and or suspicion of occult opiate use, a naloxone challenge will be performed.)
* Current history of dementia, mental retardation
* Not capable of giving informed consent for participation in the study
* Women who are pregnant or breast-feeding
* Physical conditions affecting body weight (e.g. Cushing's disease, polycystic ovary syndrome) Diabetes Mellitus (defined as prescribed an anti-diabetic medication for diabetes or a hemoglobin A1c level \> 7 confirmed by primary care physician at screening)
* Severe liver dysfunction, (serum aminotransferases greater than three times normal), acute infectious hepatitis, liver failure.
C: Inclusion Criteria:

* In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.

Exclusion Criteria:

* Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
* Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
* Contraindications or non-responsiveness for any of the treatments or other safety issues
* Expected non-compliance to treatment and/or study procedures
D: Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for participation in the current research study.

1. Subjects will be males and females between 18-60 years of age
2. Subjects will have a definite diagnosis by DSM-IV criteria of schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychotic symptoms.
3. Subjects may be outpatients or inpatients at the time of entry. They will continue in the study if hospitalization should occur.
4. The subjects or their legal guardian must sign the informed consent form.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from consideration for the current research project.

1. Subjects will be excluded if they have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis other than schizophrenia, schizoaffective disorder, bipolar disorder or depression with psychotic features; however, a concurrent diagnosis of post-traumatic stress disorder, which does not account for the subjects's psychosis is acceptable..
2. Subject has received continuous treatment of olanzapine or risperidone in the last two months.
3. Subjects receiving continuous treatment with olanzapine or risperidone in the last two months prior to entering the study will be excluded. This means the subject cannot have actually taken olanzapine or risperidone daily for more than four weeks prior to enrollment. There must be a gap of at least two days of not taking medication during that period. The dose for olanzapine cannot exceed 10 mg /day, the dose for risperidone 2 mg/day. The last day of exposure of any kind should be at least seven days before baseline.
4. Subject has been diagnosed as treatment refractory.
5. Subjects unable to speak or read the English language.
6. Subjects with a DSM-IV diagnosis of substance dependence within three months prior to selection. Occasional abuse (defined as bingeing no more than once per week) will not preclude entry.
7. Subjects with a documented disease of the central nervous system, including but not limited to stroke, tumor, Parkinson's disease, Alzheimer's disease, Huntington's disease, seizure disorder requiring anticonvulsants, history of brain trauma resulting in documented impairment, chronic infection, neurosyphilis.
8. Subjects with hepatic, renal, atherosclerotic heart disease, arrhythmias or gastrointestinal disease of sufficient degree to interfere with the excretion, absorption, and/or metabolism of trial medication.
9. Subjects with clinical signs of liver disease should be excluded.
10. Subjects with acute (e.g. infection), unstable (e.g. labile hypertension, unstable angina), significant, or untreated medical illness; patients with diastolic blood pressure \> 95 mmHg at screening should be treated and stabilized before randomization.
11. Subjects with narrow angle glaucoma, chronic urinary retention and/or clinically significant prostatic hypertrophy, paralytic ileus or related conditions, which in the opinion of the investigator may be exacerbated by the anticholinergic effects of olanzapine.
12. Subjects with a known eating disorder
13. Female subjects who are pregnant or breast-feeding
14. Subjects who are being treated with a depot neuroleptic within one treatment cycle of the beginning of the washout period.
15. Subjects with a history of neuroleptic malignant syndrome.
16. Subjects with a high-risk for suicide.

Answer: A