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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00429169
Eligibility Criteria:
Inclusion Criteria:
* Currently suffering from a major depressive episode (unipolar only)
* History of a past suicide attempt or score greater than 2 on the Hamilton Depression Rating Scale (HDRS) item #3 (suicide) at in-person screening interview. Patients with suicidal plan or intent will only be enrolled as inpatients if independent inpatient treatment team agrees.
* Patients 60 years of age and older must score at least 25 on MMSE at screening.
* Patients 60 years of age and older must have a normal ECG within the past year.
Exclusion Criteria:
* Any of the following conditions: bipolar disorder; current psychotic symptoms; bulimia or anorexia that is current or within the past year, or current purging at least twice a week for three months; already taking selective serotonin reuptake inhibitors (SSRIs) or bupropion for other indications (such as anxiety disorders)
* Primary disorder is an anxiety disorder (e.g., panic disorder, general anxiety disorder, obsessive compulsive disorder, social anxiety disorder), with secondary depression
* Drug or alcohol dependence within 6 months prior to study entry (current drug or alcohol abuse may be permitted if study officials determine that the abuse is of lesser importance than the major depressive episode)
* Systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
* Significant active physical illness, particularly those that may affect the brain or serotonergic system (e.g., blood dyscrasias lymphomas, hypersplenism, endocrinopathies, kidney failure, severe chronic obstructive lung disease, autonomic neuropathies, active malignancy)
* Active medical problems
* Requires antipsychotic medication
* History of hypomania or mania while taking antidepressants
* Any condition that may make the use of an SSRI or bupropion medically inadvisable
* Currently using Zyban
* Failure to respond to adequate trials of three SSRIs, paroxetine, or bupropion within 2 years prior to study entry (failure to respond to therapeutic trial defined as at least 2/3 maximal daily dose \[PDR\] for at least 6 weeks)
* Pregnant, breastfeeding, or plans to become pregnant during the course of study participation
* Currently on effective treatment, requires adjunctive antipsychotic or mood stabilizing medication, or is unlikely to respond to single agent treatment for depression
* Patients with ferrous metal implants in their bodies, or a history of claustrophobia that precludes MRI, will be excluded.
* Patients assessed as being unlikely to tolerate the maximum 2-week delay to start of treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00429169
Study Brief:
Protocol Section:
NCT00429169