Study of Pharmacotherapy of Psychotic Depression

Major Depressive Disorder With Psychotic Features Clinical Trial

— STOP-PD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056472
• Other study ID #: U01MH062624
• Secondary ID: U01MH062624U01MH
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2003
• Last updated: June 26, 2013
• Start date: January 2003
• Est. completion date: June 2008

Study information

• Verified date: June 2013
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder With Psychotic Features
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Olanzapine
10-20mg/day
• Sertraline
150-200mg/day

Other:
• placebo
tablet that ressembles sertraline but contains no medication

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
United States	Cornell University	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.	The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.	Weeks 1 to 12	No
Primary	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	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.	Weeks 1 to 12	No
Secondary	Scores on CGI-S Compared to Baseline Over the Course of the Trial	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.	Weeks 1 to 12	No