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Treatment of Depression With Quetiapine

Primary Purpose

Major Depression With Psychotic Features

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
quetiapine
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression With Psychotic Features focused on measuring depression, psychosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rush University Medical Center

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

Secondary Outcome Measures

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

Full Information

First Posted
September 9, 2005
Last Updated
December 28, 2007
Sponsor
Rush University Medical Center
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00174603
Brief Title
Treatment of Depression With Quetiapine
Official Title
Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit subjects
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rush University Medical Center
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression With Psychotic Features
Keywords
depression, psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
quetiapine
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale
Title
Young Mania Rating Scale
Title
Barnes Akathisia Scale
Title
Simpson Angus Scale
Title
Clinical Global Impressions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip G Janicak, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago,
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Treatment of Depression With Quetiapine

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