Treatment of Depression With Quetiapine

This study has been terminated.
(Unable to recruit subjects)
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00174603
First received: September 9, 2005
Last updated: December 28, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Major Depression With Psychotic Features
Drug: quetiapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

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

Estimated Enrollment: 60
Study Start Date: August 2005
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00174603

Locations
United States, Illinois
Rush University Medical Center
Chicago,, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
AstraZeneca
Investigators
Principal Investigator: Philip G Janicak, MD Rush University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00174603     History of Changes
Other Study ID Numbers: IRUSQUET305
Study First Received: September 9, 2005
Last Updated: December 28, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Rush University Medical Center:
depression
psychosis

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 23, 2014