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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT00179257
Eligibility Criteria:
Inclusion Criteria:
* Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses
* Ham-D 21 item score of greater than or equal to 18
* Age 18 and above
* Ability and willingness to provide consent for participation
* Failure to respond to escitalopram
Exclusion Criteria:
* Diagnosis of Bipolar Disorder or any psychotic disorder
* Alcohol or drug abuse or dependence currently or in the last 6 months
* A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
* Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
* Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
* Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent
* Presence of serious and/or unstable medical condition
* Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale
* Known sensitivity of sertraline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00179257
Study Brief:
Protocol Section:
NCT00179257