Memantine Augmentation of Antidepressants
Condition: Depressive Disorder
MeSH terms: Depressive Disorder; Depression
Intervention: memantine; Placebo
Intervention description: memantine 5mg - 20mg PO daily; 5mg - 20mg PO daily over 8 weeks
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: memantine; Namenda; augmentation; add-on; depression; MDD (major depressive disorder); unipolar depression; NMDA; ketamine; uncompetitive NMDA receptor antagonist

Summary:

      This study is evaluating the efficacy and safety of the drug memantine (trade name NAMENDA)
      as an augmentation agent for the treatment of depression in people who are not fully
      responding to antidepressant medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients between 18 and 85 years of age at screening.

          -  Patients must provide written informed consent prior to study entry.

          -  Patients must meet DSM-IV-TR (Diagnostic and Statistical Manual IV Text Revision)
             criteria for Major Depressive Episode of a severity mild, moderate or severe or in
             partial remission, as confirmed by the MINI.

          -  Patients must have a HAM-D (17-item) score of 16 or higher.

          -  Patients must have been on 1 of the following medications for 4 or more weeks at or
             above the listed dose with no psychiatric medication dose changes for the past 25
             days:

               -  20 mg qD of fluoxetine (Once Daily)

               -  50 mg qD of sertraline

               -  20 mg qD of paroxetine

               -  200 mg qD of fluvoxamine

               -  20 mg qD of citalopram

               -  10 mg qD of escitalopram

               -  150 mg qD of venlafaxine or venlafaxine sustained release

               -  300 mg qD of bupropion or bupropion sustained or extended release

               -  15 mg qD of mirtazapine

               -  60 mg qD of duloxetine

          -  Participants must agree to keep the dose of their existing antidepressant(s) constant
             throughout the 8-week trial.

        Exclusion Criteria:

          -  Diagnosis of bipolar disorder or schizophrenic or schizoaffective disorder.

          -  History of alcohol or drug abuse or dependence within 6 months of enrollment.

          -  Patients who have received ECT (Electroconvulsive Therapy) in the past 3 months.

          -  History of seizures.

          -  Moderate dementia (MMSE score of 20 or less).

          -  Active suicidal ideation: endorsing a 3 (most severe score) on QIDS-SR (Quick
             Inventory of Depression Symptomatology Self Reports) suicide item OR a score of 2 or
             higher for the past week on Suicide Scale items 4 or 5 (current suicidal ideation
             moderate or strong or would avoid taking steps to save life).

          -  Currently taking a mood stabilizer or antipsychotic (except lithium clearly used as an
             augmenting agent).

          -  Patients who, in the opinion of the investigator, might not be suitable for the study.