Depressive Disorder, MajorCOMETNCT01141387
Outcomes in MEasurement-Based Treatment
An observational study of Depressive Disorder, Major, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
Trial summary
The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- How many people
- 914 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Primary care clinic
Who may be able to join
- Age ≥18 years old
- Diagnosis of major depressive disorder
- Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days
- Primary depression management is performed by the primary care provider
- Capable of self-management (i.e., taking medications and independently responding to follow-up contacts)
- Able to provide informed consent to participate
- Sufficient ability as judged by the physician to read, understand and complete survey instruments written in English and phone interviews spoken in English
Who cannot join
- History psychotic disorder or bipolar disorder
- Diagnosis of current postpartum depression
- Diagnosis of bereavement less than 8 weeks duration
- Currently pregnant
- History of suicide attempts or current suicide plan
- Need for psychiatric hospitalization at enrollment visit
- History of adjunctive treatments including electroconvulsive treatment (ECT), vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS), magnetic seizure therapy (MST), or deep brain stimulation (DBS)
About this study
Official title: Clinical Outcomes in MEasurement-Based Treatment (COMET)
The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports.
- Conditions
- Depressive Disorder, Major
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients at the intervention sites | The intervention sites will receive the results of the patient-reported depression severity collected during the phone interviews on a monthly basis. The patients in the intervention arm will be interviewed by phone once per month for 6 months. | |
| Patients at the usual care sites | The usual care sites will receive the results of the patient-reported depression severity at the end of the study. Patients in the usual care arm will be interviewed at 3 months and 6 months post study enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
Measured: Measured at baseline
Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
Measured: Follow-up upto 6 months
Secondary outcomes (3)
Response rate assessed by the PHQ-9 instrument
Measured: 6 months
The medication prescribed including refills, dose titrations, switching and augmentation
Measured: 6 months
Health care utilizations including office visits, emergency room visits and hospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startMay 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141387
- Sponsor's protocol ID
- CN138-534
- Acronym
- COMET
- Status last verified
- Apr 2011
- First submitted
- 9 Jun 2010
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in MEasurement-Based Treatment (COMET)
- ClinicalTrials.gov ID
- NCT01141387
- Acronym / sponsor ID
- COMET / CN138-534
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Co., Ltd.
- Study start
- May 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective for this study is to assess the impact of a measurement based treatment program (MBT) on Major Depressive Disorder (MDD) remission rates in patients whose primary care provider (PCP) receives monthly patient-reported depression severity reports compared to patients whose PCP does not receive monthly reports.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients at the intervention sites | – | –The intervention sites will receive the results of the patient-reported depression severity collected during the phone interviews on a monthly basis. The patients in the intervention arm will be interviewed by phone once per month for 6 months. |
| Patients at the usual care sites | – | –The usual care sites will receive the results of the patient-reported depression severity at the end of the study. Patients in the usual care arm will be interviewed at 3 months and 6 months post study enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- Age ≥18 years old
- Diagnosis of major depressive disorder
- Prescribed a new prescription for an antidepressant medication on the date of study enrollment and currently taking the medication 'New' is defined as no antidepressant use in the previous 120 days
- Primary depression management is performed by the primary care provider
- Capable of self-management (i.e., taking medications and independently responding to follow-up contacts)
Key exclusion criteria (7 listed)
- History psychotic disorder or bipolar disorder
- Diagnosis of current postpartum depression
- Diagnosis of bereavement less than 8 weeks duration
- Currently pregnant
- History of suicide attempts or current suicide plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
Time frame: Measured at baseline
Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument
Time frame: Follow-up upto 6 months
3 secondary outcomes
Response rate assessed by the PHQ-9 instrument
Time frame: 6 months
The medication prescribed including refills, dose titrations, switching and augmentation
Time frame: 6 months
Health care utilizations including office visits, emergency room visits and hospitalization
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2013.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Otsuka Pharmaceutical Development & Commercialization, Inc..
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 7 inclusion and 7 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 8 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument (time frame: Measured at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2013.