Medication, Weight Gain and GI Hormones
Condition: Bipolar Depression
MeSH terms: Depression; Bipolar Disorder
Intervention: orally-disintegrating olanzapine; regular olanzapine
Intervention description: 5 to 20 mg (daily) orally disintegrating olanzapine for approx.8 weeks.; 5-20 mg. olanzapine daily for approximately 8 weeks.
Intervention MeSH terms: Olanzapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bipolar Depression; Weight gain bipolar medicine; side effects olanzapine; gastrointestinal hormones bipolar medicine

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.
    

Eligibility 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.