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

June 9, 2010
November 7, 2013
May 2009
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
Patient-reported depression clinical status and patient-reported global depression severity [ Time Frame: Measured at baseline and 6 monthly follow-up interviews ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01141387 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Health care utilization [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Antidepressant medication prescriptions and use [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Physician use of the MBT feedback [ Time Frame: 6 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Outcomes in MEasurement-Based Treatment
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinic

Depressive Disorder, Major
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
914
August 2010
August 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01141387
CN138-534
No
Study Director, Bristol -Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP