Outcomes in MEasurement-Based Treatment (COMET)

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01141387
First received: June 9, 2010
Last updated: November 7, 2013
Last verified: April 2011
  Purpose

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
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 ] [ Designated as safety issue: No ]
  • Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument [ Time Frame: Follow-up upto 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate assessed by the PHQ-9 instrument [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The medication prescribed including refills, dose titrations, switching and augmentation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Health care utilizations including office visits, emergency room visits and hospitalization [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141387

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol -Myers Squibb
ClinicalTrials.gov Identifier: NCT01141387     History of Changes
Other Study ID Numbers: CN138-534
Study First Received: June 9, 2010
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014