Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression
Condition: Major Depressive Disorder Without Psychotic Features
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Asenapine 5-20 mg daily; Placebo 1-4 tablets daily
Intervention description: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID; One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
Intervention MeSH terms: Asenapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Antidepressant; Antipsychotic

Summary:

      This is a 6-week comparison of asenapine versus placebo as an add-on to ongoing
      antidepressant treatment in patients with major depression who have not had a complete
      therapeutic response to treatment with the antidepressant alone.

      The investigators hypothesize that added asenapine will produce greater reductions in
      depression than will added placebo.
    

Eligibility criteria:

        Inclusion Criteria:

        -130 male or female patients, 18-65 years of age, with:

          1. DSM-IV diagnosis of MDD without psychosis (single episode or recurrent) confirmed by
             the Mini-International Neuro-psychiatric Interview (MINI)

          2. MADRS total score > 20, and item 1 (Apparent Sadness) score > 2 at enrollment and
             randomization

          3. Inadequate therapeutic response during their current depressive episode; an inadequate
             therapeutic response will be defined as continued depressive psychopathology (see
             criterion 2) following > six weeks of therapy at adequate doses (according to the US
             label) of any non-tricyclic, non-MAOI antidepressant medication

        Exclusion Criteria:

          1. Additional DSM-IV Axis I diagnoses other than Generalized Anxiety Disorder, Panic
             Disorder with or without Agoraphobia, or Social Phobia within 6 months prior to
             enrollment

          2. DSM-IV Axis II diagnoses that significantly impact the current psychiatric status

          3. Current MDD episode lasting > 12 months

          4. Electroconvulsive therapy within the preceding 6 months

          5. Substance or alcohol dependence, as defined by DSM-IV criteria, within 6 months prior
             to enrollment

          6. Unstable medical illness, epilepsy, traumatic brain injury, Parkinson disease, or
             dementia (MMSE <24)

          7. Risk of suicide as defined by MADRS item 10 score > 4

          8. Prior failure to respond to asenapine

          9. Pregnancy or failure to use an acceptable form of birth control. Pregnancy as
             determined by serum pregnancy test at baseline

         10. Hepatic impairment and history of low WBC, by medical history and interview.