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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT00429260
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of major depressive disorder,single or recurrent episode, as defined by Diagnostic and Statistical Manual of Mental Disorders DSM-IV criteria
Exclusion Criteria:
* Total score of \<22 on the Montgomery-Asberg Depression Rating Scale (MADRS).
* Duration of the current depressive episode is less than 1 month or greater than 2 years.
* Total score of \<25 on the Mini Mental State Examination (elderly patients ≥65 years only).
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 6 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry: benzodiazepines or sedative-hypnotics more than 2 days per week within 1 month, antipsychotics within 1 month, fluoxetine within 1 month, monoamine oxidase inhibitors within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week.
The investigator will evaluate whether there are other reasons why a patient may not participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00429260
Study Brief:
Protocol Section:
NCT00429260