Treatment of Depression With Quetiapine

Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram

The purpose of this study is to examine the mood stabilizing and antipsychotic properties of quetiapine in the treatment of depression by comparing subjects who were randomly assigned to either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. We hypothesize that quetiapine monotherapy would have similar effects to the combination of a first generation antipsychotic plus an antidepressant for the treatment of a major depressive episode with psychosis.

Study Overview

• Status: Terminated
• Conditions: Major Depression With Psychotic Features
• Intervention / Treatment: Drug: quetiapine

Detailed Description

Thus, current practice for treating psychotic depression is to combine an antidepressant with an antipsychotic. However, there are limitations to this approach. The rate of response is still lower than in other forms of major depression (Janicak et al., 2001). The rate of noncompliance is higher in this group; and the incidence of adverse effects related to the antipsychotic is increased (Janicak et al., 2001). As a result, studies have examined alternative treatments. The present study proposes to examine quetiapine's antipsychotic and mood stabilizing properties for the treatment of a major depressive disorder with psychotic features Subjects will be randomized to either quetipine monotherapy, quetiapine and citalopram; or haloperidol and citalopram.

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago,, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects between the ages of 18 to 75 years.
• A Structured Clinical Interview for the DSM-IV (SCID) derived diagnosis of major depression with psychosis, single or recurrent episode (unipolar or bipolar).
• Subjects may have an anxiety disorder or an additional mood disorder such as dysthymia.
• Baseline 24-item Hamilton Depression Rating Scale (HDRS) score of greater than or equal to 21.
• A baseline Positive and Negative Syndrome Scale (PANSS) score of greater than or equal to 4 on at least one of the 4 psychosis items.
• Women of childbearing potential must agree to practice a medically accepted means of contraception.
• Length of current episode no longer than 3 months.

Exclusion Criteria:

• Pregnant or lactating women
• Women of child-bearing age who refuse a pregnancy test or who refuse to use a contraceptive technique when sexually active.
• Persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; substance dependence disorder in the last 6 months; substance abuse in the last 6 months or a dementing disorder are excluded.
• Persons with serious, unstable medical illnesses.
• Subjects who have been intolerant or nonresponsive to adequate trials of quetiapine, haloperidol and/or citalopram.
• Subjects who have received an injectable decanoate medication within 1 half life of the medication (i.e, 4 weeks for haloperidol or 2 weeks for fluphenazine).
• Subjects who have received fluoxetine within 4 weeks prior to randomization.
• Subjects who have received aripiprazole within 2 weeks prior to randomization.
• Subjects who have been treated with ECT within the last 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Hamilton Rating Scale for Depression

Secondary Outcome Measures

Outcome Measure
Clinical Global Impressions
Young Mania Rating Scale
Positive and Negative Syndrome Scale
Barnes Akathisia Scale
Simpson Angus Scale

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Philip G Janicak, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): January 10, 2008
• Last Update Submitted That Met QC Criteria: December 28, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: depression; psychosis
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: IRUSQUET305