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.
1. Men and women aged 18-80 years, inclusive.
2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with
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.
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
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
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