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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT01027559
Eligibility Criteria:
DEPRESSED GROUP:
Inclusion criteria:
1. Age 18-50
2. DSM-IV criteria for major depressive disorder (MDD)
3. Minimum Hamilton Rating Scale for Depression (HAMD) score \> 18
4. Right handed
5. Capacity to give informed consent and follow study procedures
6. English speaking
Exclusion criteria:
1. Cannot give informed consent
2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures
3. Does not speak English
4. Known primary neurological disorders
5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
6. MRI contraindications e.g. foreign metallic implants, pacemaker
7. Known allergy or hypersensitivity to sertraline
8. Active suicidality
9. Severe or unstable medical illness or conditions or drugs that may cause depression
10. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, psychotic features of depression, current obsessive compulsive disorder (OCD) or panic disorder. In general, subjects with a history of other Axis I disorders prior to their depression will be excluded.
11. Current episode has failed to respond to adequate trials of two prior antidepressants for at least 6 weeks at therapeutic doses.
12. Treatment with sertraline for at least one month in past 3 months.
13. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.
14. Current psychotherapy
15. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.
CONTROL GROUP:
Inclusion criteria:
1. Age 18-50
2. No history of MDD
3. HAMD score \< 7
4. Right handed
5. Capacity to give informed consent and follow study procedures
6. English speaking
Exclusion criteria:
1. Cannot give informed consent
2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures
3. Does not speak English
4. Known primary neurological disorders
5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic)
6. MRI contraindications e.g. foreign metallic implants, pacemaker
7. Severe or unstable medical illness or conditions or drugs that may cause depression
8. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, major depression, OCD or panic disorder.
9. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics.
10. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01027559
Study Brief:
Protocol Section:
NCT01027559