The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression
Condition: Psychotic Depression
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders
Intervention: Aripiprazole
Intervention description: Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study.
Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia.
You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety and effectiveness of the combination of
      aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with
      psychotic major depression.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women aged 18-80 years, inclusive.

          2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with
             psychotic features.

          3. Inpatients who undergo a 5-7 day washout period of their medication while concurrently
             beginning one of the approved SSRI's and abilify.

          4. HAM-D-24 score > 16.

        Exclusion Criteria:

          1. Pregnant women and women of child bearing potential not using a medically accepted
             means of contraception (oral contraceptives are allowed).

          2. Women who are breast-feeding.

          3. Patients meeting DSM-IV criteria for major depression without psychotic features, or
             psychosis without major depression at the screen visit.

          4. Patients with serious suicidal risk.

          5. Patients with a history of seizure disorder; unstable physical disorders
             (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic);
             or any physical disorder judged to significantly affect central nervous system
             function.

          6. Patients meeting criteria for the following DSM-IV diagnoses: organic mental
             disorders; substance use disorders, including alcohol, active within the last 6
             months; bipolar disorder; schizoaffective disorder; or antisocial personality
             disorder.

          7. Patients who are currently taking an antidepressant, antipsychotic, or mood
             stabilizing drug and who are responding to one or all of these medications. If
             patients are not responding to these medications, they may go through a washout period
             of at least one week under the supervision of a study doctor before entering into this
             study.

          8. Patients who are not able to read and understand the consent form, or who are not
             capable of understanding or giving informed consent to the procedures of the study