Outcomes in MEasurement-Based Treatment (COMET)

Otsuka

Status: Completed

Conditions: Depressive Disorder, Major

Study type: Observational

Funder types: Industry

Identifiers

NCT01141387

CN138-534

Details and patient eligibility

About

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.

Enrollment: 914 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

914 participants in 2 patient groups

Patients at the intervention sites

Description:

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

Description:

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.