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Outcomes in MEasurement-Based Treatment (COMET)

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ClinicalTrials.gov Identifier: NCT01141387
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : November 8, 2013
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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 monthly reports.

Condition or disease
Depressive Disorder, Major

Study Type : Observational
Actual Enrollment : 914 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes in MEasurement-Based Treatment (COMET)
Study Start Date : May 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

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.

Primary Outcome Measures :
  1. Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument [ Time Frame: Measured at baseline ]
  2. Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument [ Time Frame: Follow-up upto 6 months ]

Secondary Outcome Measures :
  1. Response rate assessed by the PHQ-9 instrument [ Time Frame: 6 months ]
  2. The medication prescribed including refills, dose titrations, switching and augmentation [ Time Frame: 6 months ]
  3. Health care utilizations including office visits, emergency room visits and hospitalization [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141387

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol -Myers Squibb
ClinicalTrials.gov Identifier: NCT01141387     History of Changes
Other Study ID Numbers: CN138-534
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: November 8, 2013
Last Verified: April 2011

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms