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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT00516932
Eligibility Criteria:
Inclusion Criteria for Patients:
* Receiving treatment in an outpatient, residential, or in-patient setting
* Meets DSM-IV diagnostic criteria for at least one of the following disorders: anxiety disorder, depressive disorder, eating disorder, or obsessive-compulsive disorder
* Receiving a new prescription for an SSRI or SNRI to treat one of the above disorders
* A confirmed diagnosis of a "Suicidal Event" or "Behavioral Activation" or both following SSRI or SNRI exposure of at least 3 days duration
* Willing to provide a sample of saliva for DNA analysis
* English- or Spanish-speaking
Exclusion Criteria for Patients:
* Inpatient status IF the enrolling inpatient clinician will not continue to follow the patient for the duration of the study
* Sibling that is already enrolled in the study
* Imminently suicidal and unable to comply with a no-suicide contract or, in the opinion of the treating clinician, has inadequate family monitoring for suicidality
* Acutely psychotic at study entry
* A demonstrated lack of benefit from or intolerance to SSRI/SNRI antidepressants, as a class
* Receiving treatment with a tricyclic antidepressant (TCA) at study enrollment, with the exception of low doses for enuresis for chronic pain. Patients may receive adjunctive TCA treatment during the study at the clinician's discretion.
* Received a monoamine oxidase inhibitor (MAOI), such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate), within the past 30 days
* Parasuicidal behavior or milder forms of suicidality or activation that do not meet the diagnostic criteria
* Refusal to participate in the pharmacogenomic study
* For bipolar depressed patients, a mixed- or manic-state at study entry without stable treatment with a mood stabilizer for manic symptoms
* Patient or family is unable to comply with the protocol
Note: Tolerant controls will be ineligible if they have a past history of a treatment-emergent "Suicidal Event" or "Behavioral Activation"
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
17 Years
Study:
NCT00516932
Study Brief:
Protocol Section:
NCT00516932