The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

Official Title: “The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability”

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.

Intervention(s) in this Clinical Trial

• Drug: Aripiprazole
  • 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: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• assess the safety and efficacy of the combination of aripiprazole and SSRI in patients with psychotic major depression.
  • Time Frame: study duration
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Massachusetts General Hospital Other

Overall Clinical Trial Officials and Contacts

Matthews D John, MD Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00556140

Study ID Number: 2003-P-000990

ClinicalTrials.gov Identifier: NCT00556140

Health Authority: United States: Institutional Review Board