Please select the eligibility criteria that correspond to the clinical trial below.
Title: Orally-Disintegrating vs. Regular Olanzapine Tablets: Effects on Weight and GI Hormones
Brief Summary: This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.


Options:
A: Inclusion Criteria:

* Adults between 18 and 70 years of age were considered for inclusion if they:

  1. fulfilled the diagnostic criteria for bipolar disorder according to DSM-IV-TR,27;
  2. were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and
  3. were not underweight (BMI \> 20 kg/m2).

Exclusion Criteria:

* Pregnancy
* Actual breast feeding
* A diagnosis of anorexia nervosa or bulimia nervosa
* Diabetes type I or II or another serious physical disease
* Use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy)
* Participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder
B: Inclusion Criteria:

* Type 2 diabetes
* Overweight
* BMI of 25 kg/m2 or greater
* If on insulin, BMI of 27 kg/m2 or greater
* Blood pressure less than 160/100 mmHg
* HbA1c less or equal to 11%
* Triglycerides less than 600 mg/dl
* Willingness to participate

Exclusion Criteria:

* Unable or unwilling to give informed consent or communicate with local study staff.
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
* Hospitalization for depression in past six months.
* Self-report of alcohol or substance abuse within the past twelve months.
* Current consumption of more than 14 alcoholic drinks per week.
* Current acute treatment or rehabilitation program for these problems.
* Plans to relocate to an area not served by Look AHEAD or travel plans that do not permit full participation in the study.
* Lack of support from primary care health provider or family members.
* Failure to complete the two-week run-in for dietary intake and exercise.
* Weight loss exceeding 10 lbs. in past three months.
* Current use of medications for weight loss.
* Self reported inability to walk two blocks.
* History of bariatric surgery, small bowel resection, or extensive bowel resection.
* Chronic treatment with systemic corticosteroids.
* Another member of the household is a participant or staff member in Look AHEAD.
* Currently pregnant or nursing.
* Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured.
* HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV.
* Active tuberculosis (self-report).
* Cardiovascular disease (heart attack or procedure within the past three months).
* Participation in a cardiac rehabilitation program within last three months.
* Stroke or history/treatment for transient ischemic attacks in the past three months.
* Pulmonary embolus in past six months.
* Unstable angina pectoris or angina pectoris at rest.
* A history of cardiac arrest.
* Complex ventricular arrhythmia at rest or with exercise (e.g., ventricular tachycardia).
* Uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more).
* New York Heart Association (NYHA) Class III or IV congestive heart failure.
* Acute myocarditis, pericarditis or hypertrophic myocardiopathy.
* Clinically significant aortic stenosis.
* Left bundle branch block or cardiac pacemaker unless evaluated and cleared for participation by a cardiologist.
* Cardiac defibrillator.
* Heart transplant.
* History of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair.
* Resting heart rate less than 45 beats per minute or greater than 100 beats per minute.
* Any abnormality during the maximum exercise stress test that indicates that it would be unsafe to participate in the Lifestyle Intervention.
* Angina pectoris.
* Significant ST segment depression at low levels of exercise. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave (the J point) and the beginning of the T wave)
* Exercise induced ventricular arrhythmias.
* Abnormal hemodynamics, such as flat or decreasing systolic blood pressure with increasing workload.
* Those at moderate to high risk for cardiac complications during exercise.
* Those who are unable to self-regulate activity or understand the recommended activity level.
* Renal disease or dialysis.
* Chronic obstructive pulmonary disease that would limit ability to follow the protocol.
* Self-reported chronic hepatitis B or C or cirrhosis.
* Inflammatory bowel disease requiring treatment in past year.
* Cushing's syndrome.
* Acromegaly.
* Amputation of lower limbs as result of non-traumatic causes.
* Any major organ transplant.
C: Inclusion Criteria:

* Must be a Veteran
* Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
* Age 18-70
* Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
* Experienced weight gain since treatment with SGA's
* Inpatient or outpatient at the West Los Angeles VA
* Competent to sign informed consent

Exclusion Criteria:

* Have recently been diagnosed with schizophrenia (less than 1 year)
* Are pregnant or breast feeding a baby
* Have a medically unstable condition
D: Inclusion Criteria:

* A principal diagnosis of bipolar 1 or II disorder
* Ages 18-60
* Physically healthy
* Outpatient status
* Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15
* BMI 23-30
* Able and willing to give written informed consent

Exclusion Criteria:

* Prior history of diabetes (types I or II)
* BMI\>30
* Non-fasting blood glucose \>124
* Fasting blood glucose \>125 or random blood glucose \>200
* Presence of dyslipidemia (baseline total cholesterol \>240, HDL\<50, LDL\>160, triglycerides \>199)
* Current or past history of a non-affective psychotic disorder
* Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine)
* Current use of any nicotine products
* Schizoid, schizotypal, or borderline personality disorder
* Treatment with olanzapine in the prior 3 months or any history of non- response to or intolerance of olanzapine or the olanzapine-fluoxetine combination (SymbiaxTM)
* Suicide potential that, in the opinion of the investigator, precludes outpatient treatment or participation in a trial
* Participation of subjects in another drug trial within 30 days of evaluation
* The presence of any current medical condition judged by the investigator to potentially interfere with the study procedures or measures
* The likelihood of requiring hospitalization over the period of the study
* The presence of any clinically-significant laboratory abnormality as judged by the investigator
* Pregnancy or lactation
* History of seizure disorder, excluding febrile seizures of childhood
* Any disorder of taste or smell, including severe nasal allergies
* Any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
* Being unable to comprehend or follow the study procedures.

Answer: D