Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Intervention: Aripiprazole
Intervention description: varied dose (5, 10, 15 mg qd) for 6 wks
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: cognitive function; psychosocial function; augmentation; treatment refractory depression

Summary:

      Our target population will have been adequately treated with one of three selective serotonin
      reuptake inhibitors (SSRIs; escitalopram, citalopram, or sertraline) for at least 8-12 weeks
      and continue to experience symptoms of depression that have prompted them to seek additional
      treatment. Escitalopram, citalopram, and sertraline were selected for use in this study
      because they are among the most commonly selected SSRIs and they are associated with a
      reduced likelihood of drug-drug interactions with aripiprazole. After completion of the
      screening process, eligible participants will be augmented with aripiprazole (5, 10, or 15
      mg) for 6 weeks. Participants will continue SSRI treatment with their prescribing physician,
      in conjunction with study participation. Symptom severity will be assessed on a weekly basis,
      and cognitive and psychosocial function will be assessed at pre- and post-augmentation. We
      hypothesize that aripiprazole augmentation will be associated with reductions in symptom
      severity, and with improved performance on measures of psychosocial and cognitive function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-65

          -  Primary diagnosis of Major Depressive Disorder (MDD)

          -  Completion of at least 8-12 weeks (and no longer than 6 months) of treatment with
             escitalopram, citalopram, or sertraline, with at least 6 weeks at an adequate dose
             (i.e., 20 mg escitalopram; 40 mg citalopram; 150 mg sertraline)

          -  Hamilton Rating Scale for Depression, 17-item (HRSD17) score less than or equal to 14
             and/or Clinical Global Impression - Severity (CGI-S) score less than or equal to 3

          -  Self-reported difficulties with cognition and/or concentration, and an Inventory for
             Depressive Symptomatology Clinician-Rated, 30-item (IDS-C30) item #16 (Concentration
             and Decision Making) score less than or equal to 2

          -  Ability to read and write in English (required because instructions for cognitive
             testing and several questionnaires are available only in English)

        Exclusion Criteria:

          -  Presence of untreated or unstable comorbid medical condition based on physician
             information or evidence at examination, such as hypertension, diabetes,
             hypothyroidism.

          -  Presence of known cardiovascular disease or seizure disorder.

          -  Presence of other primary psychiatric disorders or conditions (including depression
             due to medical conditions, currently suicidal or high suicide risk, current or past
             psychotic disorders of any type, bipolar disorder (I, II, or Not Otherwise Specified
             [NOS]), schizophrenia, schizoaffective disorder, anorexia, bulimia, obsessive
             compulsive disorder, alcohol or substance abuse or dependence within the last 6
             months)

          -  Presence of organic brain injury or dementia, based on a cutoff score of < 20 on the
             Mini Mental Status Examination (MMSE).

          -  Concomitant pharmacological or psychotherapeutic treatment (in addition to one SSRI as
             described in Inclusion Criteria) including but not limited to anxiolytics,
             neuroleptics, mood stabilizers

          -  Hospitalization for mental illness within the past year.

          -  For women, currently pregnant or planning to become pregnant in the next year.