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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT00840034
Eligibility Criteria:
Inclusion Criteria:
* Meet criteria for major depressive disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR criteria)
* Meet criteria for partial response to an adequate course of treatment defined by the investigator's opinion that participant had attained at least minimal improvement on their current Selective serotonin reuptake inhibitor (SSRI) treatment
* Women of child-bearing potential must test negative for pregnancy and agree to use a reliable method of birth control
* Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal 16 to at both study entry and study enrollment
* SSRI treatment for at least 6 weeks at a stable dose for at least 2 weeks prior to study enrollment
* Stated participant preference for augmentation rather than switching antidepressant treatment
Exclusion Criteria:
* Are currently involved in or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug
* Have previously completed or withdrawn from this study or any other study investigating LY2216684
* Have had or currently have any additional ongoing DSM-IV-TR Axis 1 condition other than MDD
* Have had any anxiety disorder preceding the onset of depression that was considered the primary diagnosis within 1 year of study entry
* Have a current or previous diagnosis of Bipolar I or II, psychotic depression, schizophrenia or other psychotic disorder
* Have a history of substance abuse within the past 1 year
* Have an Axis II disorder which, in the judgment of the investigator, would interfere with compliance with the protocol
* Have had a lack of response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, the participant has treatment-resistant depression
* Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year
* Women who are pregnant or breastfeeding
* Participants who are judged to be at serious risk for harm to self or others
* Have a serious or unstable medical illness
* Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitation or retention
* Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
* Have a history of any seizure disorder (other than febrile seizures)
* Are taking noradrenergic psychotropic medications, such as tricyclic antidepressants or serotonin norepinephrine reuptake inhibitors (SNRI)
* Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to study entry
* Require psychotropic medication other than sedative/hypnotic medication for sleep
* Are taking or have received treatment with any excluded medication within 7 days prior to study enrollment
* Have a thyroid stimulating hormone (TSH ) level outside the established reference range
* Have initiate or discontinued hormone therapy within the previous 3 months prior to enrollment
* Initiation or change in intensity of psychotherapy or other non-drug therapies within 6 weeks prior to enrollment
* A positive urine drug screen for any substance of abuse at study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00840034
Study Brief:
Protocol Section:
NCT00840034