Major Depressive Disorder With Psychotic FeaturesPhase 3STOP-PDNCT00056472
Study of Pharmacotherapy of Psychotic Depression
A Phase 3 study testing Olanzapine and Sertraline in people with Major Depressive Disorder With Psychotic Features, run by Weill Medical College of Cornell University at 4 sites in 2 countries.
Trial summary
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder With Psychotic Features
- What is being tested?
- Olanzapine and Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2003to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major depressive disorder, single or recurrent, with psychotic features
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Cornell University
New York, New York, 10021
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
About this study
Official title: 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.
Read the detailed 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.
- Being tested
- Olanzapine, Sertraline, placebo
- Keywords
- Major depressive disorder with psychotic features, Delusional Depression, Randomized Trial, Combination Treatment, SSRI, Atypical Antipsychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
10-20mg/day
SertralineDrug
Also called Zoloft
150-200mg/day
placeboOther
tablet that ressembles sertraline but contains no medication
| Study group | Role | What they receive |
|---|---|---|
| olanzapine/sertraline combination | Active comparator | sertraline plus olanzapine Receives: Drug: Olanzapine; Drug: Sertraline |
| olanzapine plus placebo | Placebo comparator | olanzapine (5 - 20mg/day) plus placebo Receives: Drug: Olanzapine; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 1 to 12
Secondary outcomes (1)
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.
Measured: Weeks 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2003 (estimated)
- Study startJan 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder With Psychotic FeaturesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Barnett Meyers, MD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056472
- Sponsor's protocol ID
- U01MH062624
- Other IDs
- U01MH062624, U01MH062565, U01MH062518, U01MH062446
- Acronym
- STOP-PD
- Status last verified
- Jun 2013
- First submitted
- 14 Mar 2003
- Last updated
- 2 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34875106Bingham 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.
PubMed 29959765Bingham 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.
PubMed 28445632Gerretsen 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.
PubMed 25919834Deligiannidis 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.
PubMed 24229753Ostergaard 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.
PubMed 23799875Flint 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.
PubMed 23642462Blumberger 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.
PubMed 23609383Weissman 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.
PubMed 22464991Meyers 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.
PubMed 19652123Schaffer 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.
PubMed 18724788Smith 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.
PubMed 18408527Rothschild 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.
PubMed 18384244Andreescu 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.
PubMed 17335316
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Selective Serotonin Reuptake Inhibitors Combined With Antipsychotic Medication for the Treatment of Psychotic Depression
- ClinicalTrials.gov ID
- NCT00056472
- Acronym / sponsor ID
- STOP-PD / U01MH062624
- Keywords
- Major depressive disorder with psychotic features, Delusional Depression, Randomized Trial, Combination Treatment, SSRI, Atypical Antipsychotic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Mar 2003 (estimated)
- Results
- Posted 2 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of combining selective serotonin reuptake inhibitors (SSRIs) with antipsychotic medications in the treatment of psychotic depression.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine/sertraline combination | Active comparator | Drug: Olanzapine, Drug: Sertralinesertraline plus olanzapine |
| olanzapine plus placebo | Placebo comparator | Drug: Olanzapine, Other: placeboolanzapine (5 - 20mg/day) plus placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major depressive disorder, single or recurrent, with psychotic features
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlanzapineAlso: Zyprexa10-20mg/day | Drug | olanzapine plus placebo, olanzapine/sertraline combination |
| SertralineAlso: Zoloft150-200mg/day | Drug | olanzapine/sertraline combination |
| placebotablet that ressembles sertraline but contains no medication | Other | olanzapine plus placebo |
Primary outcome
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.
1 secondary outcome
Scores on CGI-S Compared to Baseline Over the Course of the Trial
Time frame: Weeks 1 to 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34875106Kruizinga 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.
- Derived from this study: PubMed 29959765Bingham 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.
- Derived from this study: PubMed 28445632Bingham 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.
- Derived from this study: PubMed 25919834Gerretsen 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.
- Derived from this study: PubMed 24229753Deligiannidis 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.
- Derived from this study: PubMed 23799875Ostergaard 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.
- Derived from this study: PubMed 23642462Flint 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.
- Derived from this study: PubMed 23609383Blumberger 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.
- Derived from this study: PubMed 22464991Weissman 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.
- Derived from this study: PubMed 19652123Meyers 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.
- Derived from this study: PubMed 18724788Schaffer 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.
- Derived from this study: PubMed 18408527Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barnett Meyers, MD principal investigator
Cornell University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine and Sertraline in people with Major Depressive Disorder With Psychotic Features, run by Weill Medical College of Cornell University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056472, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.