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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00976560
Eligibility Criteria:
Key Inclusion Criteria:
* Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode
* Males or Females who agree to use protocol specified contraception if of child bearing potential
* BMI 18.5-35.0 kg/m2
* Normal liver function tests
Key Exclusion Criteria:
* History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months
* Elevated liver function tests on \>2 ocassions in the last 7 months
* Significant medical illness, autoimmune disease or infectious disease
* Pregnant or nursing females
* Excessive and regular alcohol consumption
* History of substance abuse or dependence in past 6 months or positive urine drug screen
* Significant suicidal or homicidal risk
* Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid
* Psychoactive drugs within 1 week or 5 half lives of randomization visit
* Treatment resistant subjects
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00976560
Study Brief:
Protocol Section:
NCT00976560