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Outcomes in MEasurement-Based Treatment (COMET)

This study has been completed.
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: June 9, 2010
Last updated: November 7, 2013
Last verified: April 2011
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.

Depressive Disorder, Major

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcomes in MEasurement-Based Treatment (COMET)

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 914
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.


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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01141387

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

Additional Information:
Responsible Party: Study Director, Bristol -Myers Squibb Identifier: NCT01141387     History of Changes
Other Study ID Numbers: CN138-534
Study First Received: June 9, 2010
Last Updated: November 7, 2013

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms processed this record on May 25, 2017