Study of Pharmacotherapy of Psychotic Depression (STOP-PD)
Major Depressive Disorder With Psychotic Features
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression|
- 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 ] [ Designated as safety issue: No ]
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.
- Scores on CGI-S Compared to Baseline Over the Course of the Trial [ Time Frame: Weeks 1 to 12 ] [ Designated as safety issue: No ]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.
- Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week. [ Time Frame: Weeks 1 to 12 ] [ Designated as safety issue: No ]The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.
|Study Start Date:||January 2003|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Active Comparator: olanzapine/sertraline combination
sertraline plus olanzapine
Other Name: ZyprexaDrug: Sertraline
Other Name: Zoloft
Placebo Comparator: olanzapine plus placebo
olanzapine (5 - 20mg/day) plus placebo
Other Name: ZyprexaOther: placebo
tablet that ressembles sertraline but contains no medication
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056472
|United States, Massachusetts|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01605|
|United States, New York|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|University of Toronto|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Barnett Meyers, MD||Cornell University|