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 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT00562861
Eligibility Criteria:
Inclusion Criteria:
* Current age ≥18 years
* DSM-IV diagnosis of BPD, type-I, or type-II
* Current major depressive episode using DSM-IV criteria, lasting 8 weeks or longer.
* Use of lithium, divalproex, carbamazepine, or lamotrigine at therapeutic serum levels or doses for ≥4 weeks prior to study entry, or willingness to accept one of these agents.
* Prior to initial evaluations, each subject must provide competent, written, informed consent.
Exclusion Criteria:
* Past non-response to a therapeutic trial of R,S-citalopram (≥100 mg/day for ≥8 weeks).
* Previous intolerance of R,S-citalopram;
* Diagnosis of unipolar depression
* Diagnosis of schizoaffective disorder
* Serious medical illness with acute instability (cardiac, respiratory, hepatic, renal), based on hospitalization in the past month
* Abnormal thyroid function tests
* Previous allergic reaction to or inability to tolerate lithium, divalproex, or carbamazepine at therapeutic serum levels.
* Current or past renal dysfunction if taking lithium
* Current or past hepatitis or other liver disease if taking divalproex
* Current or past hematologic disease if on carbamazepine
* Severe suicidal ideation, plan or intent, as documented by a score of ≥4 on the Montgomery Åsberg Depression Rating Scale suicidality item (Item 10).
* Presence of psychosis
* Cognitive impairment sufficient to impair ability to give informed consent.
* Current pregnancy, or inability to utilize contraception
* The presence of any metallic implants
* History of claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00562861
Study Brief:
Protocol Section:
NCT00562861