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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01153867
Eligibility Criteria:
Inclusion Criteria:
* Chronic MDD as defined by the DSM-IV (meeting full criteria of MDD for at least 2 years).
* Beck Depression Inventory II (BDI-II) score at screening \>=20 (moderate to severe depression)
* Can understand and speak the Dutch language
* Has internet access at home
Exclusion Criteria:
* Acute suicide risk
* Substance induced mood disorder
* Medical condition causes depression directly or through medication intake
* MDD with psychotic features
* DSM-IV Bipolar disorder (current or past)
* DSM-IV Psychotic disorder (current or past)
* DSM-IV alcohol or drug dependence
* Autism Spectrum Disorders (Autistic Disorder, Asperger Syndrome, Pervasive developmental disorder NOS, Rett syndrome, Childhood disintegrative disorder)
* Cluster A and Cluster B personality disorders
* Started with antidepressant medication within three months prior to initial screening. Patients who receive antidepressant medication for more than 3 months prior to the start of the study can keep taking their medication and will not be excluded from participation.
* MRI contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01153867
Study Brief:
Protocol Section:
NCT01153867