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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00402220
Eligibility Criteria:
Inclusion Criteria:
Patients will be included if they:
1. Have a DSM-IV diagnosis of a major depressive episode (SCID 11).
2. Aged 18-85.
3. Have treatment resistant depression at Stage II of the Thase and Rush classification \[31\]; .e. have failed to achieve a clinical response, or did not tolerate, at least two separate antidepressant trials of sufficient dose for at least 6 weeks.
4. Have a Hamilton Depression Rating Scale Score of \> 20 (moderate - severe depression). Including only a severely ill group of subjects limits the placebo response rate \[32\]. Moreover, this will allow us to address the application of rTMS methods in the most clinically relevant subgroup of patients (in addition helping to constrain group heterogeneity, a major issue in depression research).
5. Have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to screening.
Exclusion Criteria:
1. Patients who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating.
2. In the opinion of the investigator, are a sufficient suicidal risk to require immediate electro-convulsive therapy.
3. Have a current DSM IV diagnosis of substance abuse or dependence disorder, a diagnosis of a personality disorder (SCID II) or another axis 1 disorder.
Please note: several of these criteria (e.g. inclusion criteria 1 \& 2, exclusion criteria 3) have been selected to explicitly constrain the heterogeneity of the sample to increase the likely power of the study to detect differences between the groups given the potentially subtle difference between the treatment methods.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00402220
Study Brief:
Protocol Section:
NCT00402220