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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT00532103
Eligibility Criteria:
Inclusion Criteria:
ONLY PATIENTS BEING TREATED AT THE PARTICIPATING CLINICS ARE ELIGIBLE FOR THIS STUDY
* Patients must be enrolled at the primary or specialty care site, and be planning to continue living in the area of that clinic throughout the study
* Patients must be 18-75 years old
* Patients must meet clinical criteria for MDD, based on clinical interview and DSM IV MDD checklist
* Screening HAM-D17 score greater than or equal to 14
* Patients must give written informed consent
* Patients with and without current suicidal ideation may be included in the study
* Patients must not have taken antidepressant medication for at least 2 weeks prior to screen (or 4 weeks in the case of fluoxetine).
Exclusion Criteria:
* Current substance abuse or dependence
* Two past SSRI treatment failures within the current episode, or last 2 years if chronic.
* Patients with a current Axis I diagnosis of Bipolar disorder or Schizophrenia
* Patients with a current Primary Axis I diagnosis of Obsessive-Compulsive disorder, Anorexia Nervosa or Bulimia.
* Women who are sexually active and who are not using adequate contraception, or who are pregnant, trying to become pregnant, or breast feeding.
* Patients with general medical conditions that contraindicate antidepressant medications
* Patients whose clinical status requires inpatient treatment at the time of baseline interview.
* Patients who cannot read and understand English since all research instruments are not yet translated and validated in Spanish or other languages.
* Some reports of SSRI-induced akathisia-like states have found them to be more highly correlated with either concurrent or previous treatment with a neuroleptic, even in patients with no history of movement disorders therefore, patients who have taken an anti-psychotic medication within 4 months of the screening visit will be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00532103
Study Brief:
Protocol Section:
NCT00532103