Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT00384332
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00384332
Study Brief:
Protocol Section:
NCT00384332