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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT00930293
Eligibility Criteria:
Inclusion Criteria:
* Currently in an episode of nonpsychotic major depression, as defined by the DSM-IV and documented by both the Structured Clinical Interview for Axis I, DSM-IV Disorders (SCID) and by a rating of greater than 15 on the 25-item Hamilton Rating Scale for Depression (HRSD)
* Panic spectrum risk category of at least 7, as defined by the Panic-Agoraphobic Spectrum Self-Report (PAS-SR), last month version
* Not currently receiving effective treatment
* Participants with suicidal ideation are eligible as long as outpatient treatment is deemed safe.
Exclusion Criteria:
* History of manic or hypomanic episode(s)
* History of schizophrenia or schizoaffective disorder
* Mood disorder due to a general medical condition or induced by substance use
* Presence of psychosis
* Current pregnancy or plans to become pregnant
* Current primary diagnosis of anorexia nervosa or bulimia nervosa (this does not include an eating disorder not otherwise specified \[NOS\])
* Current primary diagnosis of severe obsessive-compulsive disorder (OCD), as determined by clinician evaluation of symptom severity and temporal onset of symptoms
* Drug or alcohol abuse or dependence within the past 3 months (participants with episodic abuse related to mood episodes will not be excluded)
* Satisfies full DSM-IV criteria for antisocial personality disorder, as determined by SCID-II evaluation
* Requires inpatient treatment because of suicidal risk or psychotic symptoms (current suicidal thinking or parasuicidal behavior is not exclusionary if, in clinician judgment, it can be managed on an outpatient basis)
* Any of the following medical conditions:
1. An index episode that is secondary to the effect of medically prescribed drugs, i.e., reserpine, antihistamines, etc.
2. Presence of significant uncontrolled medical illness including cardiovascular disorder, kidney or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease (stable medical conditions such as well-controlled diabetes or HIV positive status are not exclusionary provided the participant meets other inclusion and exclusion criteria)
3. Current treatment with a pharmacologic, over-the-counter, or herbal therapy for depression or anxiety (unless the participant wishes to discontinue an ineffective treatment)
* History of poor or failed treatment response to an adequate dose and duration of citalopram
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00930293
Study Brief:
Protocol Section:
NCT00930293