The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

Last updated: July 11, 2012
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

3

Condition

Depression (Adult And Geriatric)

Depression (Major/severe)

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00556140
2003-P-000990
  • Ages 18-80
  • All Genders

Study 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

Inclusion Criteria:

  1. Men and women aged 18-80 years, inclusive.

  2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression withpsychotic features.

  3. Inpatients who undergo a 5-7 day washout period of their medication while concurrentlybeginning one of the approved SSRI's and abilify.

  4. HAM-D-24 score > 16.

Exclusion

Exclusion Criteria:

  1. Pregnant women and women of child bearing potential not using a medically acceptedmeans of contraception (oral contraceptives are allowed).

  2. Women who are breast-feeding.

  3. Patients meeting DSM-IV criteria for major depression without psychotic features, orpsychosis 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 systemfunction.

  6. Patients meeting criteria for the following DSM-IV diagnoses: organic mentaldisorders; substance use disorders, including alcohol, active within the last 6months; bipolar disorder; schizoaffective disorder; or antisocial personalitydisorder.

  7. Patients who are currently taking an antidepressant, antipsychotic, or moodstabilizing drug and who are responding to one or all of these medications. Ifpatients are not responding to these medications, they may go through a washout periodof at least one week under the supervision of a study doctor before entering into thisstudy.

  8. Patients who are not able to read and understand the consent form, or who are notcapable of understanding or giving informed consent to the procedures of the study

Study Design

Total Participants: 16
Study Start date:
June 01, 2003
Estimated Completion Date:
January 31, 2008

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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