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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT02153502
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of major depressive episode ≤ 24 months in duration
* HAM-D17 score ≥ 20.
* Documented to not have a significant (25% or greater) change in QIDS-SR16 score between Screening and Baseline visits.
* Patients have been deemed to have an inadequate response (less than 50% symptom reduction) to at least 1 but no more than 3 adequate antidepressant trials during the current depressive episode.
* Patients must be receiving ongoing treatment with an adequate dose of antidepressants.
* Body Mass Index (BMI) of 18-35 kg/m².
Exclusion Criteria:
* History of myasthenia gravis.
* Have cardiovascular concerns such as:
* History of complete heart block, QT interval corrected for heart rate (QTc) prolongation, or torsades de pointes.
* QTc using the Fridericia's formula (QTcF) at screening \> 450 msec for males and \> 470 msec for females based on central review at the screening visit, unless due to ventricular pacing.
* Any family history of congenital QT interval prolongation syndrome.
* Known hypersensitivity/intolerance to DM, Q, opiate drugs (codeine, etc.), or any other ingredient of the study medication.
* Pose a current suicide risk, as evidenced by any of the following:
* It is the judgment of the investigator that the subject may be at risk for suicide.
* The subject is rated a "yes" to question 4 or question 5 on the Baseline C-SSRS, if the most recent episode occurred within the past 12 months.
* The subject has attempted suicide within the past 6 months
* Presence of any other current DSM-IV-TR Axis I disorders with the exception of: generalized anxiety disorder (GAD: 300.02), social anxiety disorder (300.23), dysthymic disorder (300.4), or specific phobia (300.29). Patients with co-morbid GAD, social anxiety disorder, or specific phobia are ineligible if the co-morbid condition is clinically unstable, or has been the primary focus of treatment within the 6 month period prior to screening
* Axis I diagnosis of:
* Delirium, dementia, amnestic, or other cognitive disorder;
* Schizophrenia or other psychotic disorder, based on the M.I.N.I.;
* Bipolar I or II disorder, based on the M.I.N.I.
* Clinically significant Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02153502
Study Brief:
Protocol Section:
NCT02153502