Treatment of Depression With Quetiapine

Major Depression With Psychotic Features Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00174603
• Other study ID #: IRUSQUET305
• Status: Terminated
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: December 28, 2007
• Start date: August 2005
• Est. completion date: January 2007

Study information

• Verified date: December 2007
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression With Psychotic Features
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• quetiapine

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago,	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression
Secondary	Positive and Negative Syndrome Scale
Secondary	Young Mania Rating Scale
Secondary	Barnes Akathisia Scale
Secondary	Simpson Angus Scale
Secondary	Clinical Global Impressions