Treatment of Depression With Quetiapine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174603
Recruitment Status : Terminated (Unable to recruit subjects)
First Posted : September 15, 2005
Last Update Posted : January 10, 2008
Information provided by:
Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Major Depression With Psychotic Features Drug: quetiapine Phase 3

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  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram
Study Start Date : August 2005
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Hamilton Rating Scale for Depression

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale
  2. Young Mania Rating Scale
  3. Barnes Akathisia Scale
  4. Simpson Angus Scale
  5. Clinical Global Impressions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174603

United States, Illinois
Rush University Medical Center
Chicago,, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Principal Investigator: Philip G Janicak, MD Rush University Medical Center Identifier: NCT00174603     History of Changes
Other Study ID Numbers: IRUSQUET305
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 10, 2008
Last Verified: December 2007

Keywords provided by Rush University Medical Center:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Behavioral Symptoms
Mood Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs