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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT01467804
Eligibility Criteria:
Inclusion Criteria:
* Patients 18 years or older.
* A diagnosis of MDD, single episode or recurrent, according to DSM-IV
* Meets DSM-IV criteria for Major Depressive Disorder.
* factor score from the 24-item Hamilton Depression Rating Scale (HAM-D) \>20,\<35
* Patients must be able to provide written informed consent
Exclusion Criteria:
* Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
* Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
* Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
* Patients who meet criteria for any of the following DSM-IV MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern \[d\] with Psychotic Features.
* Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01467804
Study Brief:
Protocol Section:
NCT01467804