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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT00572520
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for major depressive disorder
* Score of 12 to 24 on Hamilton Depression Rating Scale (HDRS)
* Body mass index (BMI) of 30 to 40 kg
Exclusion Criteria:
* Plans to move out of the area during the study
* Current smoker
* Diagnosis of bipolar disorder, a psychotic disorder, bulimia, or post-traumatic stress disorder
* Meets criteria for severe depression (HDRS score greater than 24)
* Diagnosis of type 1 or 2 diabetes
* Plans to have bariatric surgery during the study
* No access to a telephone
* Unable to walk unaided or unable to walk 1/4 mile without stopping
* Does not have written clearance from primary care physician for physical activity
* Presence of a condition that precludes dietary changes (e.g., ulcerative colitis, Crohn's disease, active diverticulitis, renal disease)
* Presence of medical conditions likely to limit lifespan
* Taking prescription weight loss medications
* Initiation of anti-depressant medication within the 3 months prior to study entry
* Taking mood stabilizers, antipsychotic medication, or medications known to affect appetite and/or weight (e.g., corticosteroids)
* Reports active suicidal ideation via SCID interview, a score of 3 on item 24 of the HDRS (active suicidal ideation), or determined to have suicidal potential by clinical staff
* Psychiatric hospitalization in the 12 months prior to study entry
* Currently receiving psychotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT00572520
Study Brief:
Protocol Section:
NCT00572520