Status:
TERMINATED
Treatment of Depression With Quetiapine
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Major Depression With Psychotic Features
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 quetia...
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 tha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00174603
Start Date
August 1 2005
End Date
January 1 2007
Last Update
January 10 2008
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612