Outcomes in MEasurement-Based Treatment

Completed

• Conditions: Depressive Disorder, Major

• Registration Number: NCT01141387
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-04
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 914

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument	Follow-up upto 6 months

Secondary Outcome Measures

Name	Time	Method
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