Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Lifestyle Interventions and Metformin for the Treatment of Antipsychotic-Induced Weight Gain: a Randomized Double-Blind Placebo- Controlled Comparison
Brief Summary: Lifestyle intervention and certain medications have been shown to be effective for antipsychotic-induced weight gain, but no controlled studies have compared psychological and pharmacological therapies. We conducted a randomized, placebo-controlled study to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain.


Options:
A: Inclusion Criteria:

phase 1

* fulfilled DSM-IV criteria of schizophrenia or schizoaffective disorder
* 18-65 year of age
* receiving clozapine for at least 6 months.

phase 2 are those in phase 1 and met the following

* overweight and obese (BMI ≧ 24)
* one or more metabolic dysregulation, such as abdominal obesity (waist circumference \> 90 cm, in men and \> 80 cm, in women
* fasting hypertriglyceridemia, (≥ 150 mg/dL)
* low fasting HDL levels (\< 40 mg/dL in men and \< 50 mg/dL in women)
* high blood pressure (≥ 130/ ≥ 85 mm Hg or current treatment with antihypertensive medication).

The exclusion criteria are the following:

* current use of hypoglycemic or hypolipidemic agents
* FPG levels ≥ 126 mg/dL
* women who are pregnant
* known allergy or contraindicated to metformin (including Creatine\>1.4 ng/dl abnormal liver function test; chronic cardiopulmonary insufficiency).

Exclusion Criteria:

phase 2

* current use of hypoglycemic or hypolipidemic agents
* FPG levels ≥ 126 mg/dL
* women who are pregnant
* known allergy or contraindicated to metformin (including Creatine\>1.4 ng/dl abnormal liver function test
* chronic cardiopulmonary insufficiency).
B: 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
C: Inclusion Criteria:

* You must have been diagnosed with schizophrenia or schizoaffective disorder
* You must be able to visit the doctor's office once every two weeks for three months, then once every four weeks for the next three months with a possible bi-weekly visit during the fifth month
* If you are currently taking a medication for schizophrenia or schizoaffective disorder, you have been taking it for at least 30 days without any changes
* If you are a female, you must have a negative pregnancy test and be using an effective method of contraception

Exclusion Criteria:

* You have a diagnosis of bipolar I disorder, diabetes, very high triglyceride level (fasting triglycerides greater than or equal to 500 mg/dL), recent heart attack, stroke, uncontrolled seizures, serious infection, unstable heart disease (such as ischemic heart disease or congestive heart failure), an uncorrected narrow angle glaucoma or human immunodeficiency virus (HIV)
* You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood
* You have a diagnosis of an eating disorder
* You have a history of Parkinson's Disease or any related disorders
* You are allergic to sulfa drugs or any of the medications involved in this study
D: Inclusion Criteria:

* All participants met the Diagnostic and Statistical Manual of Mental Disorder-Fourth Edition (DSM-Ⅳ) criteria for schizophrenia27.
* Participants were required to get weight gain more than 10% of their predrug body weight during less than 12 months of treatment with a targeted antipsychotic agent- clozapine, olanzapine, risperidone or sulpiride.
* The duration of illness for all participants was less than 12 months.
* Participants could be taking only one antipsychotic, whose dose had not changed by changed by more than 25% over the past 3 months.
* All patients were stable outpatient.
* The total score of Positive and Negative Syndrome Scale (PANSS) for all patients could be ≤60.
* All participants were ensured that they could be carefully taken care of by one of their parents or guardians during the trial.

Exclusion Criteria:

* Participants were excluded from the study if they had evidence of liver or renal diseases, pregnant or lactating women, cardiovascular diseases, hypertension or diabetes mellitus, specific systemic diseases, or conditions that limited their ability to perform the lifestyle modifications, such as arthritis, pulmonary diseases, neurological or dietary restrictions.

Answer: D