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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00697268
Eligibility Criteria:
* INCLUSION CRITERIA:
CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS:
* age 18-65 years
* written informed consent completed (consent-incapacitated subjects will not be eligible)
* score 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
* meets DSM-IV criteria for chronic or recurrent nonpsychotic MDD
* patients who are on non-excluded concomitant medications.
* no more than 3 failed antidepressant treatments within the current major depressive episode
* no alcohol use (last 7 days)
ADDITIONAL CRITERIA FOR INCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:
* age 18 55 years
* subjects must have either a family history of mood disorders, or have a history of
multiple major depressive episodes
* age of onset of depressive symptoms less than 45 years
* no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.
* no use of benzodiazepines within 2 weeks of either MRI scan
CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS:
* age 18-65 years
* written informed consent completed
* no current or past diagnosis of axis I psychiatric disorder (DSM-IVTR)
* no alcohol use (last 7 days)
* physically healthy
ADDITIONAL CRITERIA FOR INCLUSION OF HEALTHY CONTROL SUBJECTS FOR MRI IMAGING:
* age 18 55 years
* no history of past alcohol or substance dependence (excluding nicotine) or alcohol or substance abuse (excluding nicotine) within the past year.
EXCLUSION CRITERIA:
CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS:
* history of bipolar disorder (I, II, or NOS) (lifetime)
* history of schizophrenia
* history of schizoaffective disorder or
* psychosis NOS (lifetime)
* history of anorexia nervosa or bulimia nervosa (lifetime)
* current primary obsessive-compulsive disorder (OCD) or current post traumatic stress disorder (PTSD) whose onset preceded the onset of Major Depressive Disorder
* history of clear-cut intolerability to the study medication
* lack of response to an adequate trial of the study medication (citalopram) in the current or past episodes of MDD
* did not respond to 7 or more sessions of ECT in the current episode of MDD
* Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
* has general medical condition which contraindicates the use of the study medication
* is on concomitant medication which contraindicates the use of the study medication
* requires immediate hospitalization for psychiatric disorder
* requires antipsychotic medications or mood stabilizers
* Non-postmenopausal (less than 2 years since last period) females of childbearing potential who are sexually active and who are not using adequate (hormonal, double barrier, surgical) contraception, or who are pregnant or breast feeding
* patients currently taking any of the exclusionary medications detailed in protocol (including antipsychotic medications, anticonvulsant medications, antidepressant medications, mood stabilizers, central nervous system stimulants) in the 2 weeks prior to Study Period II.
* patients taking thyroid medication for hypothyroidism may be included if they have been stable on the medication for greater than 3 months
* patients can participate in a modality of psychotherapy that is not targeting the symptoms of depression (e.g., supportive therapy, marital therapy)
* therapy that is depression specific, such as Cognitive Therapy (CT) or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation
* subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent.
* current alcohol dependence or abuse (last 3 months)
* patient has a prolonged QTc (greater than or equal to 450 msec), as shown on ECG
* Current NIMH employee/staff or their immediate family member.
ADDITIONAL CRITERIA FOR EXCLUSION OF DEPRESSED PATIENTS FOR MRI IMAGING:
* subjects meeting general exclusion criteria for MRI scanning (e.g. implanted cardiac pacemaker, intraocular metal) will be excluded from the MRI procedures only.
* subjects with structural lesions visible on MRI will be excluded from further MRI procedures
* subjects with diabetes or hypertension will be excluded
CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:
* subjects currently taking any of the exclusionary medications detailed in protocol in the 2 weeks prior to evaluation
* current alcohol dependence or abuse (last 3 months)
* history of major depression or bipolar disorder in any first degree relative
ADDITIONAL CRITERIA FOR EXCLUSION OF HEALTHY CONTROL SUBJECTS:
* subjects meeting general exclusion criteria for MRI scanning (e.g. implanted cardiac pacemaker, intraocular metal) will be excluded from the MRI procedures only.
* subjects with structural lesions visible on MRI will be excluded from further MRI procedures
* subjects with diabetes or hypertension will be excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00697268
Study Brief:
Protocol Section:
NCT00697268