Skip to main content
OpenTrials
Completed

NCT Number: NCT00056472

Study of Pharmacotherapy of Psychotic Depression

This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder With Psychotic Features

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Toronto, Toronto, Ontario, Canada

Loading trial locations.

About this study

Approximately 25% of people who are admitted to hospitals for depression suffer from psychotic depression. People with psychotic depression experience hallucinations,and, more commonly delusions, in addition to major depression. Psychotic experiences may be either congruent with the theme of depression or incongruent, without an apparent relationship to feeling depressed. This study will determine the effectiveness of combining a selective serotonin reuptake inhibitor (SSRI) with antipsychotic medication in the treatment of psychotic depression accompanied by at least one identifiable delusion. The study will also evaluate the difference in treatment response of young adults versus geriatric patients.

This double-blind study will last a total of 12 weeks. Participants will be randomly assigned to receive either olanzapine, an atypical antipsychotic drug, combined with sertraline, an SSRI, or olanzapine alone. Following baseline assessments, study visits will occur weekly until Week 6, and then bi-weekly until Week 12. Participants who do not respond to either treatment may leave the study at any time. Participants who achieve either partial or full response may participate in an additional 20-week study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Major depressive disorder, single or recurrent, with psychotic features

Exclusion criteria

  • History of substance abuse or dependence within the 3 months prior to enrollment
  • Acute or unstable medical illness
  • Diagnosis of schizophrenia or other psychotic disorders
  • Pregnant
  • Intolerance to SSRIs or olanzapine

Treatment and study plan

Olanzapine

Drug

10-20mg/day

Other names: Zyprexa

Sertraline

Drug

150-200mg/day

Other names: Zoloft

Placebo

Other

tablet that ressembles sertraline but contains no medication

Primary outcomes

  1. Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial

    Time frame: Weeks 1 to 12

    Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.

    Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior.

Secondary outcomes

  1. Scores on CGI-S Compared to Baseline Over the Course of the Trial

    Time frame: Weeks 1 to 12

    A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.

Other outcomes

  1. Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.

    Time frame: Weeks 1 to 12

    The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression

Acronym: STOP-PD

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Mar 17, 2003
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.