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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00834834
Eligibility Criteria:
Inclusion Criteria:
* Meets Diagnostic and Statistical Manual (DSM-IV) criteria for borderline personality disorder (BPD)
* Attempted suicide in the past 2 months
* At least one additional suicide attempt, suicide-related behavior, or self-injury episode in the past year
* Current suicidal ideation
* Able to be managed as an outpatient
* Not currently receiving optimum psychiatric treatment and agrees to notify study staff if any psychiatric care outside this study is sought. If care other than that permitted by the protocol is utilized, participants can no longer be enrolled in the study.
* Has a stable living arrangement at study entry
* Speaks English
* Willing and judged to be clinically able to undergo wash-out of psychotropic medications, except for occasional benzodiazepines use, for 2 to 6 weeks before treatment
* Females must be willing to use an effective method of birth control.
Exclusion Criteria:
* Meets the DSM-IV criteria for mental retardation or the following disorders: bipolar I, schizophrenia, delusional disorder, schizophreniform disorder, schizoaffective disorder, or psychotic disorder not otherwise specified (NOS)
* Needs priority treatment for acute medical illness or other debilitating problem, such as severe substance dependence or anorexia
* Pregnant
* Clinically too unstable to be maintained as an outpatient
* Has clearly failed adequate trials of fluoxetine and citalopram for a major depression in the past 2 years
* History of severe allergies, adverse drug reactions, or known allergy to fluoxetine or citalopram
* Clinically inadvisable for the participant to end current treatment
* Heart pacemaker body implant; other metal implants, such as shrapnel or surgical prostheses; or paramagnetic objects contained within the body, as assessed via a metal screening questionnaire, which may present a risk to the participant or interfere with the fMRI scan
* Diagnosed with Raynaud's disorder
* History of hypertension, cardiovascular disease, or abnormal electrocardiograms (EKGs)
* Claustrophobia or significant discomfort in enclosed space
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00834834
Study Brief:
Protocol Section:
NCT00834834