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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT06392867
Eligibility Criteria:
Inclusion Criteria:
* are aged between 18 and 70;
* have a MDD diagnosis, single or recurrent episode, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria and confirmed by means of the Mini-International Neuropsychiatric Interview (MINI);
* have a score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HDRS17) in their current episode;
* have failed to have a clinically significant response to two or more standard antidepressant treatments during their current episode;
* have received stable psychopharmacological treatment within 4 weeks prior to screening; and
* have normal thyroid function, Complete Blood Count, electrolytes, and liver enzyme levels based on pre-study blood work.
Exclusion Criteria:
* have a history of substance abuse or dependence in the past 3 months;
* have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump;
* show active suicidal intent (MADRS item 10 score \>4);
* are pregnant;
* have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms;
* have a metal implant or any other common MRI and TMS exclusion criteria;
* take antiepileptic drugs or benzodiazepines corresponding to a dose of \>1 mg lorazepam per day;
* have had initiation or dose change of any psychotropic medication in the 4 weeks prior to screening or
* have undergone TMS in the past.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06392867
Study Brief:
Protocol Section:
NCT06392867