Medication, Weight Gain and GI Hormones

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Eli Lilly and Company
• Treatments: Hormones; Olanzapine

Criteria

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.