Abilify as an Adjunctive Treatment for Refractory Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Aripiprazole
Intervention description: Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive aripiprazole augmentation. There is no comparator group.
Intervention MeSH terms: Aripiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depression; Depression; Unipolar Depression; Treatment Resistant Depression; Adjunctive treatment

Summary:

      This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical
      antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI)
      antidepressant treatment for depressed outpatients who are not responding fully to SSRI
      treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of
      treatment with Aripiprazole and SSRI medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female outpatients between the ages of 18 and 70.

          -  Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV)
             diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type

          -  Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at
             baseline

          -  Patients who have had treatment with an SSRI at an adequate dose (see Table for a
             minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2)

          -  Patients who agree to use acceptable method of birth control throughout the study

        Exclusion Criteria:

          -  Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or
             other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional
             (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe
             Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.

          -  Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence
             on any drug, including alcohol.

          -  Patients who are pregnant or nursing women.

          -  Patients who would pose a serious risk for suicide during the course of the study, as
             evidenced by one of the following: (a) report of having a specific plan for killing
             themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3
             as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last
             6 months which required medical attention, such as an emergency room visit or which is
             considered by the treating physician to have been possibly life threatening

          -  Patients with unstable medical conditions such as untreated or uncontrolled
             hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure>150/90),
             cardiovascular disease, diabetes, HIV (by report of patient).

          -  Patients with a history of seizures.