Depressive Disorder, Major
Conditions
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.
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument | Measured at baseline |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed