Skip to main content
OpenTrials
Completed

NCT Number: NCT01141387

Outcomes in MEasurement-Based Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

Clinical Outcomes in MEasurement-Based Treatment (COMET)

Acronym: COMET

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2010
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.