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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT00076258
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Major Depressive Disorder
* Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
* 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
* Sedentary lifestyle
* Physically capable of exercise
* Body mass index (BMI) less than 40 kg/m2
* Willing and able to comply with study requirements
Exclusion Criteria:
* Significant cardiovascular disease or other medical conditions
* Uncontrolled hypertension
* Abnormal exercise stress test
* Hematologic disorders
* Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
* Alcohol and/or substance abuse in the past 6 months
* Hospitalization for mental illness within the past year
* High suicide risk
* Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
* Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
* Significantly elevated blood lipids
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00076258
Study Brief:
Protocol Section:
NCT00076258