Please select the eligibility criteria that correspond to the clinical trial below.
Title: Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting.
Brief Summary: Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.


Options:
A: Inclusion criteria:

1. English-speaking men and women (20-50 years old) of all ethnic origins
2. Outpatients with a current DSM-IV diagnosis of bipolar I with or without psychotic features or bipolar II disorder
3. Current cocaine or methamphetamine dependence
4. Currently experiencing hypomanic, manic, or mixed state episodes with a Young Mania Rating Scale23 (YMRS11) score of \> 9
5. Currently craving stimulants with a craving score of \> 20 on the 10-item, self-reported Stimulant Craving Questionnaire24 (SCQ10)
6. A high school diploma, GED, or Shipley IQ test score of \>85.

Exclusion criteria:

1. Inpatients or anyone with a high risk for suicide (i.e., active suicidal ideation with a proposed plan, history of any suicide attempt within the last 6 months)
2. DSM-IV diagnosis of substance-induced mood disorder
3. Pregnant or breast-feeding
4. History of special education, mental retardation, dementia
5. HIV/AIDS, reactive hepatitis, hepatic cirrhosis or any active liver disease, personal or familial history of diabetes, personal history of heart disease (i.e., congenital heart abnormalities, congestive heart failure, chronic atrial fibrillation, rheumatic heart disease, heart attack)
6. Central nervous system diseases (e.g., multiple sclerosis, severe head trauma, or seizures)
7. Contraindications or allergic reactions to study medications
8. Currently participating in any other research program
9. Urine positive for glucose or ketones
10. Currently receiving any antipsychotic medications or more than two psychotropic medications
11. Currently receiving benzodiazepines, sedatives or stimulants
12. Any other current substance dependence
13. Cataracts or glaucoma
14. EKG evidence of QT prolongation.
B: Inclusion Criteria:

* Ages 18-65
* Schizophrenia or schizoaffective disorder
* Meets the Structured Clinical Interview for DSM-IV (SCID) criteria for an alcohol use disorder
* Alcohol use on at least 5 days during the 4 weeks prior to randomization
* Patient is medically stable to start either form of risperidone.

Exclusion Criteria:

* Current treatment with clozapine.
* Current treatment with injectable risperidone long-acting.
* Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
* Change in medications (dose of current medication, discontinuation of medication, or new medication) in past 30 days.
* History of or current breast cancer.
* History of intolerance of or allergy to risperidone or risperidone long-acting.
* Currently residing in a residential program designed to treat substance use disorders.
* Current treatment with long-acting, injectable antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
* Past treatment with risperidone long-acting will require a review by the medication adjustment group before entering the client into the study.
* Treatment at baseline with a second antipsychotic medication will require a review by the medication adjustment group before entering the client into the study.
* Treatment at baseline with a psychotropic agent proposed to curtail substance use will require a review by the medication adjustment group before entering the client into the study.
* Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study.
C: Inclusion Criteria:

* Meets diagnosis criteria for Bipolar I Disorder - Most Recent Episode Manic (Diagnostic and Statistical Manual of Mental Diseases, 4th edition, (DSM-IV))
* meets DSM-IV criteria for a current manic episode
* hospitalized voluntarily at study initiation
* history of at least one documented manic or mixed episode prior to study initiation
* total score of \>=20 on the Young Mania Rating Scale (YMRS) and total score of \<=20 on the Montgomery Asberg Depression Rating Scale (MADRS) at start of the study

Exclusion Criteria:

* Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling
* borderline or antisocial personality disorder
* history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation
* seizure disorder
* females who are pregnant or nursing, or those lacking adequate contraception.
D: Inclusion Criteria:

* Psychosis
* Must be able to use oral antipsychotic drugs

Exclusion Criteria:

* Mania
* Unable to cooperate with the assessments
* Unable to understand Norwegian language
* Candidates for electroconvulsive therapy
* Use of Clozapine at admittance

Answer: D