Treatment of Depression With Quetiapine

Condition(s) targeted: Major Depression With Psychotic Features

Intervention: quetiapine (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Rush University Medical Center

Official(s) and/or principal investigator(s):
Philip G Janicak, MD, Principal Investigator, Affiliation: Rush University Medical Center

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Hamilton Rating Scale for Depression

Secondary outcome:

Positive and Negative Syndrome Scale

Young Mania Rating Scale

Barnes Akathisia Scale

Simpson Angus Scale

Clinical Global Impressions

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

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

Starting date: August 2005
Ending date: January 2007
Last updated: December 28, 2007