Psychotic DepressionPhase 4STOP-PDNCT01427608
Sustaining Remission of Psychotic Depression
A Phase 4 study testing Sertraline + Olanzapine in people with Psychotic Depression, run by Weill Medical College of Cornell University at 4 sites in 2 countries.
Trial summary
The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psychotic Depression
- What is being tested?
- Sertraline + Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2011to 30 Nov 2017
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85 years, inclusive
- Diagnosis: Diagnostic Statistical Manual-IV Trade Revision (DSM IV-TR) non-bipolar major depression with psychotic features established by both clinical interview with research psychiatrist and administration of SCID-IV.
- Score >2 on Schedule for Affective Disorders (SADS) delusion severity item
- Score >1 on any of the three conviction items of the Delusion Assessment Scale (DAS) (does not alter belief in response to reality testing)
- 17-item HAM-D score of >20
Who cannot join
- Current or lifetime DSM-IV-TR history of schizophrenia or other psychotic disorders or meeting current criteria for brief psychotic disorder, body dysmorphic disorder or obsessive-compulsive disorder
- Current or lifetime DSM-IV-TR bipolar affective disorder
- History of DSM-IV-TR defined alcohol or substance abuse or dependence within the past three months
- Dementia or clinically significant cognitive impairment prior to index episode of depression, and/or a mean score >3 on 26-item caregiver assessment
- Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset before age 35, and/or diabetes mellitus complicated by prior documented episode of ketoacidosis
- Acute or unstable medical illness within the past 3 months; current abnormal serum free T4; current abnormally low vitamin B4 or folic acid level; medical conditions and/or medications for which psychotic or depressive symptoms can be a direct manifestation; neurological disease associated with extrapyramidal signs and symptoms; epilepsy, if the person has had one or more grand mal seizures within the past 12 months.
Show all 12Show fewer
- The need for treatment with any psychotropic medication other than sertraline, olanzapine or lorazepam; or with an anticonvulsant medication with mood-stabilizing properties.
- Current pregnancy or plan to become pregnant during the course of the study; breast feeding in women with infants.
- A documented history of being unable to tolerate olanzapine or sertraline including significant bradycardia (heart rate of <50 bpm), and serum sodium level of 129mmol/L or below.
- History of non-response of the index episode of psychotic depression to at least a 6-week trial of at least 150mg/day sertraline combined with 15mg/day olanzapine
- Patients showing ongoing improvement in current episode of psychotic depression with treatment other than sertraline or olanzapine
- Patients who are in immediate need of electroconvulsive therapy (ECT) (imminent risk of suicide, refusing to eat, catatonic)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Ellen Whyte, MD
Pittsburgh, Pennsylvania, 15213
George Alexopoulos, MD
White Plains, New York, 10605
Anthony Rothschild, MD
Worcester, Massachusetts, 01605
About this study
The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. It is predicted that this combination will improve symptoms of psychotic depression and be associated metabolic side effects. Factors that moderate tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks, followed by a period of 8 weeks during which participants will continue to take the same medications to stabilize the remission from symptoms of psychotic depression.
The maintenance phase will be a randomized, double-blind, placebo-controlled study of olanzapine for a period of up to 36 weeks to test whether continuing this combination decreases the risk of relapse and whether discontinuing the combination leads to improvement in metabolic measures. Subjects who complete the acute phase will be asked to consent separately to the randomized maintenance phase.
Read the detailed description
The original STOP-PD study established that the combination of olanzapine and sertraline was significantly better than olanzapine alone in achieving remission of psychotic depression. This STOP-PD-II Sustaining Remission study aims to assess the long-term tolerability of taking this combination of medications and their efficacy at preventing a relapse of the symptoms. The acute phase of the study will monitor the efficacy and tolerability of the olanzapine and sertraline combination, including investigation of weight and metabolic variables, age effects on treatment response and tolerability, and the association of genetic polymorphisms to response or relapse. When subjects are stabilized on these medications for a period of 8 weeks they will be invited to participate in the randomized phase of the research: the olanzapine will be placebo-controlled, meaning half of the subjects will continue to take the olanzapine/sertraline combination and half will take a sertraline/placebo combination, for a period of 36 weeks. Symptoms and side effects will be monitored regularly throughout this phase. Randomization will be stratified on a 1:1 basis by age 60 and above.
- Conditions
- Psychotic Depression
- Being tested
- Sertraline + Olanzapine, Sertraline + Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline + OlanzapineDrug
Also called Zyprexa
Olanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening
Sertraline + PlaceboDrug
Also called Placebo
Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.
| Study group | Role | What they receive |
|---|---|---|
| Sertraline + Olanzapine | Active comparator | Randomized to continue with sertraline and olanzapine under double-blind conditions. Receives: Drug: Sertraline + Olanzapine |
| Sertraline + Placebo | Placebo comparator | Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions. Receives: Drug: Sertraline + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects at Risk of Relapse During the Randomized Phase.
Relapse criteria include at least one of the following:
1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of >17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of >2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
Measured: From entry into randomized phase (baseline) and 36 weeks or earlier relapse
Secondary outcomes (3)
Changes in Metabolic Measures: Weight
Change in weight from entry into randomized phase (baseline) and 36 weeks.
Measured: From entry into randomized phase (baseline) and 36 weeks
Changes in Metabolic Measure: Cholesterol
Change in cholesterol from entry into randomized phase (baseline) and 36 weeks.
Measured: From entry into randomized phase (baseline) and 36 weeks
Changes in Metabolic Measures: Triglycerides
Change in triglycerides from entry into randomized phase (baseline) and 36 weeks.
Measured: From entry into randomized phase (baseline) and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startOct 2011
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
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 (7)Papers the sponsor has linked to this study.
- Other trials for Psychotic DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of Massachusetts, Worcester, University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- George Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell UniversityAlastair Flint, MD, Principal investigator, University of TorontoAnthony Rothschild, MD, Principal investigator, University of Massachusetts, WorcesterEllen Whyte, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427608
- Sponsor's protocol ID
- STOP-PD-II
- Acronym
- STOP-PD
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2011
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Neufeld NH, Oliver LD, Mulsant BH, Alexopoulos GS, Hoptman MJ, Tani H, Marino P, Meyers BS, Rothschild AJ, Whyte EM, Bingham KS, Flint AJ, Voineskos AN. Effects of antipsychotic medication on functional connectivity in major depressive disorder with psychotic features. Mol Psychiatry. 2023 Aug;28(8):3305-3313. doi: 10.1038/s41380-023-02118-8. Epub 2023 May 31.
PubMed 37258617Bingham KS, Calarco N, Dickie EW, Alexopoulos GS, Butters MA, Meyers BS, Marino P, Neufeld NH, Rothschild AJ, Whyte EM, Mulsant BH, Flint AJ, Voineskos AN. The relationship of white matter microstructure with psychomotor disturbance and relapse in remitted psychotic depression. J Affect Disord. 2023 Aug 1;334:317-324. doi: 10.1016/j.jad.2023.04.136. Epub 2023 May 4.
PubMed 37149056Flint AJ, Bingham KS, Alexopoulos GS, Marino P, Mulsant BH, Neufeld NH, Rothschild AJ, Voineskos AN, Whyte EM, Meyers BS; STOP-PD II Study Group. Predictors of relapse of psychotic depression: Findings from the STOP-PD II randomized clinical trial. J Psychiatr Res. 2023 Jan;157:285-290. doi: 10.1016/j.jpsychires.2022.12.011. Epub 2022 Dec 12.
PubMed 36535116Voineskos AN, Mulsant BH, Dickie EW, Neufeld NH, Rothschild AJ, Whyte EM, Meyers BS, Alexopoulos GS, Hoptman MJ, Lerch JP, Flint AJ. Effects of Antipsychotic Medication on Brain Structure in Patients With Major Depressive Disorder and Psychotic Features: Neuroimaging Findings in the Context of a Randomized Placebo-Controlled Clinical Trial. JAMA Psychiatry. 2020 Jul 1;77(7):674-683. doi: 10.1001/jamapsychiatry.2020.0036.
PubMed 32101271Flint AJ, Meyers BS, Rothschild AJ, Whyte EM, Alexopoulos GS, Rudorfer MV, Marino P, Banerjee S, Pollari CD, Wu Y, Voineskos AN, Mulsant BH; STOP-PD II Study Group. Effect of Continuing Olanzapine vs Placebo on Relapse Among Patients With Psychotic Depression in Remission: The STOP-PD II Randomized Clinical Trial. JAMA. 2019 Aug 20;322(7):622-631. doi: 10.1001/jama.2019.10517.
PubMed 31429896Bingham KS, Whyte EM, Mulsant BH, Rothschild AJ, Rudorfer MV, Marino P, Banerjee S, Butters MA, Alexopoulos GS, Meyers BS, Flint AJ; STOP-PD Study Group. Health-related quality of life in remitted psychotic depression✰. J Affect Disord. 2019 Sep 1;256:373-379. doi: 10.1016/j.jad.2019.05.068. Epub 2019 May 28.
PubMed 31207561Flint AJ, Meyers BS, Rothschild AJ, Whyte EM, Mulsant BH, Rudorfer MV, Marino P; STOP-PD II Study Group. Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD II. BMC Psychiatry. 2013 Jan 25;13:38. doi: 10.1186/1471-244X-13-38.
PubMed 23351522
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustaining Remission of Psychotic Depression
- ClinicalTrials.gov ID
- NCT01427608
- Acronym / sponsor ID
- STOP-PD / STOP-PD-II
- Conditions
- Psychotic Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, University of Massachusetts, Worcester, University of Pittsburgh
- Study start
- Oct 2011
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The acute phase of this study will monitor the response to a combination of an atypical antipsychotic medication olanzapine with an antidepressant medication sertraline in the acute treatment of the disorder. It is predicted that this combination will improve symptoms of psychotic depression and be associated metabolic side effects. Factors that moderate tolerability will be monitored. Improvement in symptoms could take between 4 and 12 weeks, followed by a period of 8 weeks during which participants will continue to take the same medications to stabilize the remission from symptoms of psychotic depression.
The maintenance phase will be a randomized, double-blind, placebo-controlled study of olanzapine for a period of up to 36 weeks to test whether continuing this combination decreases the risk of relapse and whether discontinuing the combination leads to improvement in metabolic measures. Subjects who complete the acute phase will be asked to consent separately to the randomized maintenance phase.
Detailed description
The original STOP-PD study established that the combination of olanzapine and sertraline was significantly better than olanzapine alone in achieving remission of psychotic depression. This STOP-PD-II Sustaining Remission study aims to assess the long-term tolerability of taking this combination of medications and their efficacy at preventing a relapse of the symptoms. The acute phase of the study will monitor the efficacy and tolerability of the olanzapine and sertraline combination, including investigation of weight and metabolic variables, age effects on treatment response and tolerability, and the association of genetic polymorphisms to response or relapse. When subjects are stabilized on these medications for a period of 8 weeks they will be invited to participate in the randomized phase of the research: the olanzapine will be placebo-controlled, meaning half of the subjects will continue to take the olanzapine/sertraline combination and half will take a sertraline/placebo combination, for a period of 36 weeks. Symptoms and side effects will be monitored regularly throughout this phase. Randomization will be stratified on a 1:1 basis by age 60 and above.
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 |
|---|---|---|
| Sertraline + Olanzapine | Active comparator | Drug: Sertraline + OlanzapineRandomized to continue with sertraline and olanzapine under double-blind conditions. |
| Sertraline + Placebo | Placebo comparator | Drug: Sertraline + PlaceboRandomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-85 years, inclusive
- Diagnosis: Diagnostic Statistical Manual-IV Trade Revision (DSM IV-TR) non-bipolar major depression with psychotic features established by both clinical interview with research psychiatrist and administration of SCID-IV.
- Score >2 on Schedule for Affective Disorders (SADS) delusion severity item
- Score >1 on any of the three conviction items of the Delusion Assessment Scale (DAS) (does not alter belief in response to reality testing)
- 17-item HAM-D score of >20
Key exclusion criteria (12 listed)
- Current or lifetime DSM-IV-TR history of schizophrenia or other psychotic disorders or meeting current criteria for brief psychotic disorder, body dysmorphic disorder or obsessive-compulsive disorder
- Current or lifetime DSM-IV-TR bipolar affective disorder
- History of DSM-IV-TR defined alcohol or substance abuse or dependence within the past three months
- Dementia or clinically significant cognitive impairment prior to index episode of depression, and/or a mean score >3 on 26-item caregiver assessment
- Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset before age 35, and/or diabetes mellitus complicated by prior documented episode of ketoacidosis
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 |
|---|---|---|
| Sertraline + OlanzapineAlso: ZyprexaOlanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening | Drug | Sertraline + Olanzapine |
| Sertraline + PlaceboAlso: PlaceboTaper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study. | Drug | Sertraline + Placebo |
Primary outcome
Number of Subjects at Risk of Relapse During the Randomized Phase.
Time frame: From entry into randomized phase (baseline) and 36 weeks or earlier relapse
Relapse criteria include at least one of the following: 1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of >17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of >2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
3 secondary outcomes
Changes in Metabolic Measures: Weight
Time frame: From entry into randomized phase (baseline) and 36 weeks
Changes in Metabolic Measure: Cholesterol
Time frame: From entry into randomized phase (baseline) and 36 weeks
Changes in Metabolic Measures: Triglycerides
Time frame: From entry into randomized phase (baseline) and 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37258617Neufeld NH, Oliver LD, Mulsant BH, Alexopoulos GS, Hoptman MJ, Tani H, Marino P, Meyers BS, Rothschild AJ, Whyte EM, Bingham KS, Flint AJ, Voineskos AN. Effects of antipsychotic medication on functional connectivity in major depressive disorder with psychotic features. Mol Psychiatry. 2023 Aug;28(8):3305-3313. doi: 10.1038/s41380-023-02118-8. Epub 2023 May 31.
- Derived from this study: PubMed 37149056Bingham KS, Calarco N, Dickie EW, Alexopoulos GS, Butters MA, Meyers BS, Marino P, Neufeld NH, Rothschild AJ, Whyte EM, Mulsant BH, Flint AJ, Voineskos AN. The relationship of white matter microstructure with psychomotor disturbance and relapse in remitted psychotic depression. J Affect Disord. 2023 Aug 1;334:317-324. doi: 10.1016/j.jad.2023.04.136. Epub 2023 May 4.
- Derived from this study: PubMed 36535116Flint AJ, Bingham KS, Alexopoulos GS, Marino P, Mulsant BH, Neufeld NH, Rothschild AJ, Voineskos AN, Whyte EM, Meyers BS; STOP-PD II Study Group. Predictors of relapse of psychotic depression: Findings from the STOP-PD II randomized clinical trial. J Psychiatr Res. 2023 Jan;157:285-290. doi: 10.1016/j.jpsychires.2022.12.011. Epub 2022 Dec 12.
- Derived from this study: PubMed 32101271Voineskos AN, Mulsant BH, Dickie EW, Neufeld NH, Rothschild AJ, Whyte EM, Meyers BS, Alexopoulos GS, Hoptman MJ, Lerch JP, Flint AJ. Effects of Antipsychotic Medication on Brain Structure in Patients With Major Depressive Disorder and Psychotic Features: Neuroimaging Findings in the Context of a Randomized Placebo-Controlled Clinical Trial. JAMA Psychiatry. 2020 Jul 1;77(7):674-683. doi: 10.1001/jamapsychiatry.2020.0036.
- Derived from this study: PubMed 31429896Flint AJ, Meyers BS, Rothschild AJ, Whyte EM, Alexopoulos GS, Rudorfer MV, Marino P, Banerjee S, Pollari CD, Wu Y, Voineskos AN, Mulsant BH; STOP-PD II Study Group. Effect of Continuing Olanzapine vs Placebo on Relapse Among Patients With Psychotic Depression in Remission: The STOP-PD II Randomized Clinical Trial. JAMA. 2019 Aug 20;322(7):622-631. doi: 10.1001/jama.2019.10517.
- Derived from this study: PubMed 31207561Bingham KS, Whyte EM, Mulsant BH, Rothschild AJ, Rudorfer MV, Marino P, Banerjee S, Butters MA, Alexopoulos GS, Meyers BS, Flint AJ; STOP-PD Study Group. Health-related quality of life in remitted psychotic depression✰. J Affect Disord. 2019 Sep 1;256:373-379. doi: 10.1016/j.jad.2019.05.068. Epub 2019 May 28.
- Derived from this study: PubMed 23351522Flint AJ, Meyers BS, Rothschild AJ, Whyte EM, Mulsant BH, Rudorfer MV, Marino P; STOP-PD II Study Group. Sustaining remission of psychotic depression: rationale, design and methodology of STOP-PD II. BMC Psychiatry. 2013 Jan 25;13:38. doi: 10.1186/1471-244X-13-38.
- Individual participant dataSharing planned: No
Related trials for Psychotic Depression
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Not yet recruiting
A Mobile App to Support Mood, Daily Routines and Medication Adherence in Adults With Severe Mental Illness
Severe Mental Illness, Bipolar Disorder
Active, not recruitingObservational study
Validation and Comparative Multi-Omics Benchmarking of Fluid-Derived Volatilomics Biomarkers for the Prevention and Early Detection of Schizophrenia
Schizophrenia / Schizoaffective Disorder
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.
George Alexopoulos, MD principal investigator
Weill Medical College of Cornell University
Alastair Flint, MD principal investigator
University of Toronto
Anthony Rothschild, MD principal investigator
University of Massachusetts, Worcester
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline + Olanzapine in people with Psychotic Depression, 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 5 inclusion and 12 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 5 Mar 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 5 Mar 2019). 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?
Number of Subjects at Risk of Relapse During the Randomized Phase. (time frame: From entry into randomized phase (baseline) and 36 weeks or earlier relapse). 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 NCT01427608, which also lists 7 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 5 Mar 2019.