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:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT01919216
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 24-75 years
* Diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) IV Major Depressive Disorder, nonpsychotic
* 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16
* Willing to and capable of providing informed consent and complying with study procedures
* Subjects are right-handed
* Using appropriate contraceptive method if woman of child-bearing age
Exclusion Criteria:
* Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment Disorder, Panic Disorder, Generalized Anxiety Disorder, or Social Phobia
* Diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within the past 12 months
* History of psychosis or psychotic disorder, mania or bipolar disorder
* Subject is considered to be at significant risk of suicide based on current mental status and recent history
* History of allergic or adverse reaction to citalopram, or nonresponse to adequate trial of citalopram (at least 4 weeks at dose of 40mg) or escitalopram (at least 4 weeks at dose of 20mg)
* Subject is considered based on history to be unlikely to respond to the single agent citalopram (i.e., subjects with treatment resistant depression)
* Current treatment with psychotherapy
* Clinical Global Impression (CGI)-Severity score of 7 at baseline Clinical Interview
* Current or recent (within the past 4 weeks) treatment with any of the following: antidepressants, antipsychotics, mood stabilizers, isoniazid, glucocorticoids, opiates, centrally active antihypertensive drugs (e.g. clonidine, reserpine)
* Subject has metal in body or prior history working with metal fragments (e.g., as a machinist), tattoos, or unable to tolerate the scanning procedures (i.e., severe obesity, claustrophobia)
* Acute, severe, or unstable medical illness
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
24 Years
Maximum Age:
75 Years
Study:
NCT01919216
Study Brief:
Protocol Section:
NCT01919216