Efficacy, Safety, and Tolerability Study of AVP-786 as an Adjunctive Therapy in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

This is an interventional treatment trial for Depressive Disorder, Treatment-Resistant Read More

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.