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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT00696293
Eligibility Criteria:
Inclusion Criteria:
* Age \>/= 60
* Current episode of MDD per SCID DSM-IV criteria
* Must score \>/= 16 on the CES-D assessment
* Serum sodium \>/=130 mEq/ml
* CLBP of at least moderate severity for more days than not for \>/= 3 months
* MADRS score \>/= 15
* Sufficiently medically stable to be able to participate in a depression treatment protocol
* Willingness and ability to speak English Access to translators is limited. It would be unsafe to treat an older adult who does not speak English with an antidepressant and not be able to effectively communicate with them about their progress and any side effects. We provide a 24/7 on-call service for all subjects enrolled in this study. The on-call clinicians and physicians are not bilingual, and if a problem arose, it may be impossible to effectively interpret and manage the emergent situation. Finally, many of the assessments used in the study are self-reports. At the present time, we do not have the ability to translate these instruments into other languages. If the subject cannot read and understand English, this would interfere with their ability to complete the self-report assessments
* Willingness to discontinue other antidepressants and anxiolytics, except for lorazepam up to 2 mg/day
* Mini Mental State Exam \> 20
* Willingness to provide informed consent
* Corrected visual ability that enables reading of newspaper headlines and hearing capacity that is adequate to respond to a raised conversational voice.
Exclusion Criteria:
* Meet DSM-IV criteria for dementia
* History of bipolar, schizophrenia, schizoaffective, or other psychotic disorder
* Alcohol or other drug abuse (including abuse of prescription medications) within the past 6 months
* History of treatment non-adherence in other protocols run by the Mid-Life or Late-Life Centers
* Acute pain superimposed on chronic pain. For example, subjects who report "red flags" which suggest a herniated disk, vertebral fracture, infection, cauda equina syndrome, or other medical emergency will be excluded
* Wheelchair bound
* History of documented non-response to duloxetine
* Concurrent use of thioridazine
* Active suicidal ideation with plan
* Uncontrolled narrow angle glaucoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00696293
Study Brief:
Protocol Section:
NCT00696293