Status:
COMPLETED
Medication, Weight Gain and GI Hormones
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
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 tr...
Detailed Description
Olanzapine is undeniably one of the most effective treatments available for all phases of bipolar disorder. After FDA approval for bipolar mania, the drug became one of the most widely prescribed of t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00384332
Start Date
January 1 2007
End Date
March 1 2010
Last Update
July 31 2017
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212