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 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT00331305
Eligibility Criteria:
Inclusion Criteria:
* DSM-IV diagnosis of major depressive disorder (MDD)
* Score of greater than 11 on the Beck Depression Inventory (BDI)
Exclusion Criteria:
* Primary psychiatric diagnosis other than major depressive disorder (e.g., bipolar disorder)
* Any of the following DSM-IV diagnoses: dementia or delirium; obsessive compulsive disorder (OCD); schizophrenia, schizoaffective, or other psychotic disorder; psychotic features, including any delusions or hallucinations during the current depressive episode; current alcohol or other substance abuse disorder; acute risk for suicide (e.g., score of greater than 2 on the suicide item on the HAM-D) or acute risk for homicide
* May require treatment with additional psychotherapeutic agents (other than chloral hydrate for sleep) during the course of the study
* Significant medical conditions that may cause an increased risk for a significant adverse experience during the course of the trial (e.g., unstable angina, myocardial infarction within 3 months of study entry, etc.)
* Unable to be randomly assigned to the study drug due to a risk for adverse cardiac events, such as prolonged QT interval, use of other medications that would be counterindicated for use with sertraline, or other conditions that may make study participation unsafe
* Unable to be randomly assigned to an exercise condition due to medical conditions such as musculoskeletal problems or abnormal cardiac response to exercise (e.g., exercise-induced ventricular tachycardia, abnormal blood pressure response, etc.)
* Currently receiving antidepressant medication or actively engaged in psychotherapy
* Currently exercising regularly
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00331305
Study Brief:
Protocol Section:
NCT00331305