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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00456820
Eligibility Criteria:
Inclusion Criteria:
1. Ages 18 - 60 years and able to give voluntary informed consent.
2. Satisfy criteria for recent treatment with for Major Depressive Episode using DSM-IV episode recently treated with an adequate dose of an SSRI (sertraline, paroxetine, fluoxetine, citalopram, escitalopram) with 17-item Hamilton Depression Rating Scale (HDRS) score \< 18.
3. Complaining of symptoms of apathy, lack of feeling or sexual dysfunction with AES score \< 10 and/or MADRAS item 8 (inability to feel \> 1) and/or CSFQ score \> 10
4. Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire. 5) Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following - Symptoms not worsening by more than 10 points on the HDRS during the course of the study and not representing danger to self or others.
Exclusion Criteria:
1. Meeting DSM-IV criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, atypical psychosis, primary anxiety disorder, mental retardation, or organic mental (including organic mood) disorder.
2. Use of neuroleptic in the past 1 year.
3. History of seizure disorder
4. History of eating disorders such as bulimia or anorexia nervosa
5. History of lack of response or intolerance to bupropion.
6. Use of mood stabilizers in the past 2 weeks.
7. Use of benzodiazepines in the past 2 weeks.
8. Acutely suicidal or homicidal or requiring inpatient treatment.
9. Meeting DSM-IV criteria for other substance dependence, including alcohol within the 6 months, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
10. Use of alcohol in the past 1 week.
11. No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
12. Abnormal TSH values. If on synthroid should be on a stable dose for 3 months prior to the study with no changes during the study.
13. Current pregnancy or breast-feeding.
14. Metallic implants.
15. Previously known positive HIV blood test (as latent central dysfunction may be present) as reported by the subject.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00456820
Study Brief:
Protocol Section:
NCT00456820