NCT00939250

Brief Summary

The study involves a 32-week randomized controlled trial in primary care of a comprehensive diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD, compared to a group treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

July 13, 2009

Last Update Submit

September 1, 2020

Conditions

Type 2 DiabetesMajor Depressive Disorder

Keywords

DiabetesDepressionDisease Self ManagementMeasurement Based Care

Outcome Measures

Primary Outcomes (1)

  • Glycosylated Hemoglobin

    week 16, 32

Secondary Outcomes (1)

  • Quick Inventory of Depressive Symptoms - Self Report

    week 16, 32

Study Arms (2)

Diabetes and depression intervention

EXPERIMENTAL

Measurement based care for diabetes and depression, disease self management for diabetes and depression

Behavioral: Diabetes and depression intervention

Diabetes intervention

ACTIVE COMPARATOR

Measurement based care for diabetes, disease self management for diabetes

Behavioral: Diabetes intervention

Interventions

Diabetes and depression interventionBEHAVIORAL

Disease self management for diabetes and depression

Also known as: Measurement based care, Disease self management
Diabetes and depression intervention
Diabetes interventionBEHAVIORAL

Disease self management for diabetes

Also known as: Measurement based care, Disease self management
Diabetes intervention

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV criteria for single or recurrent nonpsychotic MDD, and whom the physician deems it necessary to start on an antidepressant.
  • Meets clinical criteria for type 2 diabetes as follows: (1) on pharmacological treatment for type 2 diabetes and/or (2) fasting plasma glucose \> 126mg/dL on 2 separate occasions or an abnormal oral glucose tolerance test (OGTT) (2-hours post load glucose ≥ 200mg/dL).
  • HbA1C \> 7
  • Ability and willingness to provide written informed consent
  • Hamilton Rating Scale for Depression (HRSD) score ≥ 14
  • Not on antidepressant medication for at least 2 weeks prior to screen (or 6 weeks in the case of fluoxetine or monoamine oxidase inhibitors - MAOIs)

You may not qualify if:

  • Women who are pregnant or breastfeeding
  • Type 1 diabetes
  • General medical conditions that contraindicate use of antidepressant medications
  • Unstable medical illnesses, such as uncontrolled hypertension or symptomatic cardiovascular disease, such as congestive heart failure or angina
  • Current or past psychotic disorders including bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder; anorexia; bulimia
  • High risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior
  • Concomitant pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy; cognitive behavioral therapy; current use of other medications that would be contraindicated with antidepressant treatment, as determined by the study doctor
  • History of current substance or alcohol dependence requiring detoxification within the last 6 months
  • Currently suicidal or considered a high suicide risk
  • Require inpatient treatment for their depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family and Community Medicine Clinic, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Depressive Disorder, MajorDiabetes MellitusDepression

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDepressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Madhukar H. Trivedi, M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

  • David W. Morris, Ph.D.

    University of Texas Southwestern Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2009

First Posted

July 14, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 2, 2020

Record last verified: 2020-09

Locations

US(1)