Treatment of Depression With Quetiapine

NCT00174603 | Terminated Phase 3

• 1 other identifier: IRUSQUET305
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression With Psychotic Features

Keywords

depression; psychosis

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression

Secondary Outcomes (5)

• Positive and Negative Syndrome Scale

• Young Mania Rating Scale

• Barnes Akathisia Scale

• Simpson Angus Scale

• Clinical Global Impressions

Interventions

quetiapine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Depression; Psychotic Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Philip G Janicak, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2005
• Study Completion: January 1, 2007
• Last Updated: January 10, 2008

Record last verified: 2007-12

Locations

US (1)