NCT00056472

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_3

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

August 2, 2013

Completed
Last Updated

August 2, 2013

Status Verified

June 1, 2013

Enrollment Period

5.4 years

First QC Date

March 14, 2003

Results QC Date

June 16, 2009

Last Update Submit

June 26, 2013

Conditions

Major Depressive Disorder With Psychotic Features

Keywords

Major depressive disorder with psychotic featuresDelusional DepressionRandomized TrialCombination TreatmentSSRIAtypical Antipsychotic

Outcome Measures

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

    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

Secondary Outcomes (1)

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

    Weeks 1 to 12

Other Outcomes (1)

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

    Weeks 1 to 12

Study Arms (2)

olanzapine/sertraline combination

ACTIVE COMPARATOR

sertraline plus olanzapine

Drug: OlanzapineDrug: Sertraline

olanzapine plus placebo

PLACEBO COMPARATOR

olanzapine (5 - 20mg/day) plus placebo

Drug: OlanzapineOther: placebo

Interventions

OlanzapineDRUG

10-20mg/day

Also known as: Zyprexa
olanzapine plus placeboolanzapine/sertraline combination
SertralineDRUG

150-200mg/day

Also known as: Zoloft
olanzapine/sertraline combination
placeboOTHER

tablet that ressembles sertraline but contains no medication

olanzapine plus placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Cornell University

New York, New York, 10021, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Toronto

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (14)

  • Kruizinga J, Liemburg E, Burger H, Cipriani A, Geddes J, Robertson L, Vogelaar B, Nolen WA. Pharmacological treatment for psychotic depression. Cochrane Database Syst Rev. 2021 Dec 7;12(12):CD004044. doi: 10.1002/14651858.CD004044.pub5.

    PMID: 34875106DERIVED

  • Bingham KS, Meyers BS, Mulsant BH, Rothschild AJ, Whyte EM, Banerjee S, Artis AS, Alexopoulos GS, Flint AJ; STOP-PD Study Group. Stabilization treatment of remitted psychotic depression: the STOP-PD study. Acta Psychiatr Scand. 2018 Sep;138(3):267-273. doi: 10.1111/acps.12937. Epub 2018 Jun 29.

    PMID: 29959765DERIVED

  • Bingham KS, Rothschild AJ, Mulsant BH, Whyte EM, Meyers BS, Banerjee S, Szanto K, Flint AJ; STOP-PD Study Group. The Association of Baseline Suicidality With Treatment Outcome in Psychotic Depression. J Clin Psychiatry. 2017 Sep/Oct;78(8):1149-1154. doi: 10.4088/JCP.16m10881.

    PMID: 28445632DERIVED

  • Gerretsen P, Flint AJ, Whyte EM, Rothschild AJ, Meyers BS, Mulsant BH. Impaired insight into delusions predicts treatment outcome during a randomized controlled trial for Psychotic Depression (STOP-PD study). J Clin Psychiatry. 2015 Apr;76(4):427-33. doi: 10.4088/JCP.14m09003.

    PMID: 25919834DERIVED

  • Deligiannidis KM, Rothschild AJ, Barton BA, Kroll-Desrosiers AR, Meyers BS, Flint AJ, Whyte EM, Mulsant BH; STOP-PD Study Group. A gender analysis of the study of pharmacotherapy of psychotic depression (STOP-PD): gender and age as predictors of response and treatment-associated changes in body mass index and metabolic measures. J Clin Psychiatry. 2013 Oct;74(10):1003-9. doi: 10.4088/JCP.13m08400.

    PMID: 24229753DERIVED

  • Ostergaard SD, Meyers BS, Flint AJ, Mulsant BH, Whyte EM, Ulbricht CM, Bech P, Rothschild AJ; STOP-PD Study Group. Measuring psychotic depression. Acta Psychiatr Scand. 2014 Mar;129(3):211-20. doi: 10.1111/acps.12165. Epub 2013 Jun 25.

    PMID: 23799875DERIVED

  • Flint AJ, Iaboni A, Mulsant BH, Rothschild AJ, Whyte EM, Meyers BS; STOP-PD Study Group. Effect of sertraline on risk of falling in older adults with psychotic depression on olanzapine: results of a randomized placebo-controlled trial. Am J Geriatr Psychiatry. 2014 Apr;22(4):332-6. doi: 10.1016/j.jagp.2013.01.067. Epub 2013 May 2.

    PMID: 23642462DERIVED

  • Blumberger DM, Mulsant BH, Kanellopoulos D, Whyte EM, Rothschild AJ, Flint AJ, Meyers BS. The incidence of tardive dyskinesia in the study of pharmacotherapy for psychotic depression. J Clin Psychopharmacol. 2013 Jun;33(3):391-7. doi: 10.1097/JCP.0b013e31828bf059.

    PMID: 23609383DERIVED

  • Weissman J, Flint A, Meyers B, Ghosh S, Mulsant B, Rothschild A, Whyte E; STOP-PD Study Group. Factors associated with non-completion in a double-blind randomized controlled trial of olanzapine plus sertraline versus olanzapine plus placebo for psychotic depression. Psychiatry Res. 2012 May 30;197(3):221-6. doi: 10.1016/j.psychres.2012.02.015. Epub 2012 Mar 31.

    PMID: 22464991DERIVED

  • Meyers BS, Flint AJ, Rothschild AJ, Mulsant BH, Whyte EM, Peasley-Miklus C, Papademetriou E, Leon AC, Heo M; STOP-PD Group. A double-blind randomized controlled trial of olanzapine plus sertraline vs olanzapine plus placebo for psychotic depression: the study of pharmacotherapy of psychotic depression (STOP-PD). Arch Gen Psychiatry. 2009 Aug;66(8):838-47. doi: 10.1001/archgenpsychiatry.2009.79.

    PMID: 19652123DERIVED

  • Schaffer A, Flint AJ, Smith E, Rothschild AJ, Mulsant BH, Szanto K, Peasley-Miklus C, Heo M, Papademetriou E, Meyers BS. Correlates of suicidality among patients with psychotic depression. Suicide Life Threat Behav. 2008 Aug;38(4):403-14. doi: 10.1521/suli.2008.38.4.403.

    PMID: 18724788DERIVED

  • Smith E, Rothschild AJ, Heo M, Peasley-Miklus C, Caswell M, Papademetriou E, Flint AJ, Mulsant BH, Meyers BS; STOP-PD Collaborative Study Group. Weight gain during olanzapine treatment for psychotic depression: effects of dose and age. Int Clin Psychopharmacol. 2008 May;23(3):130-7. doi: 10.1097/YIC.0b013e3282f424d6.

    PMID: 18408527DERIVED

  • Rothschild AJ, Winer J, Flint AJ, Mulsant BH, Whyte EM, Heo M, Fratoni S, Gabriele M, Kasapinovic S, Meyers BS; Study of Pharmacotherapy of Psychotic Depression (STOP-PD) Collaborative Study Group. Missed diagnosis of psychotic depression at 4 academic medical centers. J Clin Psychiatry. 2008 Aug;69(8):1293-6. doi: 10.4088/jcp.v69n0813.

    PMID: 18384244DERIVED

  • Andreescu C, Mulsant BH, Peasley-Miklus C, Rothschild AJ, Flint AJ, Heo M, Caswell M, Whyte EM, Meyers BS; STOP-PD Study Group. Persisting low use of antipsychotics in the treatment of major depressive disorder with psychotic features. J Clin Psychiatry. 2007 Feb;68(2):194-200. doi: 10.4088/jcp.v68n0203.

    PMID: 17335316DERIVED

MeSH Terms

Interventions

OlanzapineSertraline

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Barnett S. Meyers, MD
Organization
Weill Cornell Medical College
bmeyers@med.cornell.edu
914-997-5721

Study Officials

  • Barnett Meyers, MD

    Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2003

First Posted

March 17, 2003

Study Start

January 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 2, 2013

Results First Posted

August 2, 2013

Record last verified: 2013-06

Locations

US(3)CA(1)