Outcomes in MEasurement-Based Treatment

NCT01141387 | Completed

• 1 other identifier: CN138-534
• Study Type: observational
• Target: 914
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (2)

• Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument

  Measured at baseline

• Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument

  Follow-up upto 6 months

Secondary Outcomes (3)

• Response rate assessed by the PHQ-9 instrument

  6 months

• The medication prescribed including refills, dose titrations, switching and augmentation

  6 months

• Health care utilizations including office visits, emergency room visits and hospitalization

  6 months

Study Arms (2)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Related Links

• BMS Clinical Trials Disclosure
• Investigator Inquiry form
• For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 8, 2013

Record last verified: 2011-04