Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Naltrexone and Bupropion Combination on Weight Loss and Smoking Cessation in Obese, Cigarette-smoking Patients With Schizophrenia
Brief Summary: The purpose of this research is to observe the efficacy of Naltrexone and Bupropion combination on weight loss and smoking cessation from baseline to week 24 compare to placebo.


Options:
A: Inclusion Criteria:

* DSM diagnoses that have an FDA indication for atypical antipsychotic use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of Early Onset Schizophrenia Spectrum (EOSS; schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS); Bipolar Spectrum (bipolar I, II and NOS); Major depressive disorder with psychosis; Mood disorder NOS corresponding to Leibenluft and colleagues severely mood dysregulated (SMD) broad spectrum bipolar disorder; Mood disorder NOS corresponding to irritability associated with autism spectrum disorders; or - for adult teen participants aged 18-19 years - Major depressive disorder. Diagnoses will be determined by clinical interview, Leibenluft's modification of the K-SADS-PL, and the "Aberrant Behavior Checklist" (cutoff score of 18, as used by FDA for approval of risperidone and aripiprazole in minors).
* Clinically stable on current treatment regimen for at least 30 days, as assessed in a three-step process
* Current SGA treatment with olanzapine, quetiapine, risperidone, ziprasidone aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine for ≥ 8 weeks
* Stable dose of current SGA and psychotropic co-medications for at least 30 days
* Body mass index (BMI) at least in the 85th percentile for age and gender
* Substantial weight gain over the previous 3 years while taking a SGA, as reflected by family and referring physician's judgment. The weight gain did not have to occur on the child's current SGA. Weight needs to have remained stable or increased over past year.
* Agrees to use two effective forms of birth control or to remain abstinent
* Has a primary caretaker who has known the child well for at least 6 months before study entry
* Primary caretaker is able to participate in study appointments as clinically indicated

Exclusion Criteria:

* Treatment with any medication (other than the currently prescribed psychotropic medications) that would significantly alter glucose, insulin, or lipid levels. Exception: orlistat and amantadine are permitted if the individual has taken the drug for at least one year without weight loss.
* Major neurological or medical illness that affects weight gain or that would prevent participation in physical activities
* Fasting glucose levels indicating need for prompt treatment
* Pediatrician or pediatric gastroenterologist recommendation to address abnormal fasting labs by pursuing more active treatment than those in the 2007 American Medical Association guidelines
* Diagnosis of anorexia nervosa or bulimia nervosa, as based on current or lifetime DSM-IV criteria
* Diagnosis of substance dependence disorder (other than tobacco dependence) within the past month, as based on DSM-IV criteria
* Positive urine toxicology indicating ongoing use of illicit substance
* Current treatment with more than one antipsychotic medication
* Current treatment with more than 3 total psychotropic medications (i.e., 2 psychotropics plus SGA), with the exception of subjects taking 2 medications for ADHD in which a total of 4 psychotropic medications are allowed.
* Known hypersensitivity to metformin
* Prior treatment with aripiprazole and perphenazine for more than 2 weeks that was stopped for inefficacy or intolerability
* Pregnant, breastfeeding, or unwilling to comply with contraceptive requirements of study
* IQ score less than 55
* Significant risk of dangerousness to self or to others that would make study participation inadvisable
* Language issues that prevent child and/or parent from completing assessments or treatment
* Ongoing or previously undisclosed child abuse requiring new department of social service intervention
B: Inclusion Criteria:

* Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS, Autism Spectrum Disorder
* Patients will be currently treated with antipsychotics

Patients will qualify for entry if they meet the following weight criteria:

1. The patient has gained 7% of their weight since beginning of treatment with one or more of the current antipsychotics.
2. The patient has had an increase of 7% of their weight during the last year while being treated with antipsychotics.
3. The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months while being treated with antipsychotic medications.
4. The patient has a BMI of 35 or greater at the current time, and his chart shows a history of consistent weight gain over the past 1 to 3 years during treatment with antipsychotics.

   .

   Exclusion Criteria:
   * Subjects will be excluded if they have asthma, peptic ulcer disease (diseases which may be exacerbated by a histamine analog), or history of pheochromocytoma or peptic ulcer disease. Patients will be excluded if they are prescribed medications known to affect body weight or glucose-lipid metabolism, such as prescription or over the counter medications taken for the purpose of weight reduction. Subjects who are currently treated with metformin, for less than 6 months and have shown recent weight change on metformin. Patients on thyroid replacement therapy or lipid-lowering agents whose dosage has changed by more than 50 % in the past month will be excluded. If they are relatively stable doses of these medications they will not be excluded. Patients who are on lipid lowering medication, thyroid replacement medication, or diabetes medication, (excluding metformin), must remain on these medications throughout the period of the study. Females who are pregnant or breast feeding will be excluded.
C: Inclusion Criteria:

* diagnosis of schizophrenia by the International Classification of Diseases 10th Revision (ICD-10);
* age between 18 and 65 years old;
* on stable antipsychotic medication treatment for at least one month;
* BMI \> 28 kg/m2 according to BMI criterion for obesity in the Chinese population ， or BMI\>27 kg/m2 in the presence of dyslipidemia, or male with waist circumference over 90cm;
* smoking at least 10 cigarettes daily for one year or longer;
* desire to lose weight and quit smoking.

Exclusion Criteria:

* Binge eating or other eating disorders;
* Current use of weight loss or antidiabetic medications;
* Current substance use (except nicotine or caffeine);
* Elevated hepatic transaminase levels (\>2.5x normal range);
* Clinically significant Thyroid Stimulating Hormone（TSH） and/or thyroxine4（T4） abnormalities;
* History of seizure disorder;
* History of unstable cardiac problems or other unstable medication conditions;
* Being pregnant or nursing (for women).
D: Inclusion Criteria:

* Schizophrenia, schizophreniform disorder, or schizoaffective disorder with psychotic symptoms
* Free of depot antipsychotic medication for at least 6 months. Oral antipsychotic medication at entry into the study is allowed, provided the participant has not had an adequate trial during the present episode of psychosis.
* If taking antidepressant or mood stabilizing medication, stable dosing for at least 30 days prior to entry.
* Good physical health

Exclusion Criteria:

* Risperidone (RIS), olanzapine (OLA)\*, or molindone (MOL) for 8 weeks or more during THIS episode, with 2 weeks at the maximal dose (6 mg/day of RIS, 20 mg/day of OLA, or 140 mg/day of MOL)
* If using antidepressant and/or mood stabilizing medications, treatment for fewer than 30 days immediately before entry
* Intolerance or nonresponse to RIS, OLA\*, or MOL during any previous treatment
* Bipolar affective disorder,post traumatic stress disorder, personality disorder, or psychosis not otherwise specified
* Currently meeting Diagnostic and Statistical Manual version IV (DSM IV) criteria for major depression episode
* DSM IV criteria for substance abuse or dependence with intention to continue illicit substance abuse
* Endocrinological or neurological conditions which confound the diagnosis or are a contraindication to treatment with antipsychotics
* Mental retardation
* Risk of suicide or homicide that is not adequately controlled in the current setting
* Pregnancy or refusal to practice contraception during the study

"\*" OLA exclusion not applicable after 11/2005

Answer: C