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CompletedNCT01141387COMETUpdated Nov 8, 2013

Outcomes in MEasurement-Based Treatment

An observational study in Depressive Disorder, Major, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-08.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
914
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Depressive Disorder, Major
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In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's enrollment of 914 is above the median of 135 across 365 observational studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 293 studies on the registry; 18 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 70 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
914 participants (actual)

Groups and 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.

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01141387
First posted
Jun 10, 2010
Start date
May 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Nov 8, 2013

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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