Study of Pharmacotherapy of Psychotic Depression (STOP-PD)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00056472
First received: March 14, 2003
Last updated: June 26, 2013
Last verified: June 2013

March 14, 2003
June 26, 2013
January 2003
June 2008   (final data collection date for primary outcome measure)
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.

Not Provided
Complete list of historical versions of study NCT00056472 on ClinicalTrials.gov Archive Site
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.
Not Provided
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.
Not Provided
 
Study of Pharmacotherapy of Psychotic Depression
Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder With Psychotic Features
  • Drug: Olanzapine
    10-20mg/day
    Other Name: Zyprexa
  • Drug: Sertraline
    150-200mg/day
    Other Name: Zoloft
  • Other: placebo
    tablet that ressembles sertraline but contains no medication
  • Active Comparator: olanzapine/sertraline combination
    sertraline plus olanzapine
    Interventions:
    • Drug: Olanzapine
    • Drug: Sertraline
  • Placebo Comparator: olanzapine plus placebo
    olanzapine (5 - 20mg/day) plus placebo
    Interventions:
    • Drug: Olanzapine
    • Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
259
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00056472
U01 MH62624, U01MH062624, U01 MH62565, U01 MH62518, U01 MH62446
Yes
Weill Medical College of Cornell University
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: Barnett Meyers, MD Cornell University
Weill Medical College of Cornell University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP