Outcomes in MEasurement-Based Treatment

Depressive Disorder, Major Clinical Trial

— COMET  

Official title:

Clinical Outcomes in MEasurement-Based Treatment (COMET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141387
• Other study ID #: CN138-534
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: November 7, 2013
• Start date: May 2009
• Est. completion date: August 2010

Study information

• Verified date: April 2011
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Otsuka Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument		Measured at baseline	No
Primary	Remission rate assessed by the Patient Health Questionnaire - 9 item (PHQ-9) instrument		Follow-up upto 6 months	No
Secondary	Response rate assessed by the PHQ-9 instrument		6 months	No
Secondary	The medication prescribed including refills, dose titrations, switching and augmentation		6 months	No
Secondary	Health care utilizations including office visits, emergency room visits and hospitalization		6 months	No

External Links

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