Antidepressant Medications for Type 2 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Type 2 Diabetes+6 MoreAntidepressant Medications - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether a modernized collaborative care intervention for depression can improve the diabetes risk markers of hemoglobin A1c and insulin resistance, and whether somatic depressive symptoms moderate the effect of the intervention on diabetes risk markers.

Eligible Conditions
  • Type 2 Diabetes
  • Prediabetes
  • Depression
  • Insulin Resistance
  • Dysthymia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline and 6 months

Baseline and 6 months
Change in Hemoglobin A1c at 6 months
Change in Homeostatic Model of Assessment (HOMA) score at 6 months

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

eIMPACT
2%Hospitalization for depression/suicidal ideation
2%Emergency department visit for depression/suicidal ideation
1%Diarrhea following study-initiated suicidal ideation
1%Suspected drug overdose
1%Passive suicidal ideation
1%Petechiae on hand/wrist due to blood pressure cuff inflation during brachial FMD assessment
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02458690) in the eIMPACT ARM group. Side effects include: Hospitalization for depression/suicidal ideation with 2%, Emergency department visit for depression/suicidal ideation with 2%, Diarrhea following study-initiated suicidal ideation with 1%, Suspected drug overdose with 1%, Passive suicidal ideation with 1%.

Trial Design

2 Treatment Groups

Active Control
1 of 2
eIMPACT-DM intervention
1 of 2

Active Control

Experimental Treatment

64 Total Participants · 2 Treatment Groups

Primary Treatment: Antidepressant Medications · No Placebo Group · Phase 2

eIMPACT-DM interventionExperimental Group · 3 Interventions: Antidepressant Medications, Good Days Ahead (GDA), Problem Solving Treatment in Primary Care (PST-PC) · Intervention Types: Drug, Behavioral, Behavioral
Active Control
Other
ActiveComparator Group · 1 Intervention: Active Control · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Norepinephrine
FDA approved
Problem Solving Treatment in Primary Care (PST-PC)
2015
Completed Phase 2
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 months

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,148 Previous Clinical Trials
4,074,685 Total Patients Enrolled
Indiana UniversityLead Sponsor
877 Previous Clinical Trials
759,491 Total Patients Enrolled
Jesse C Stewart, PhDPrincipal InvestigatorIndiana University-Purdue University Indianapolis (IUPUI)
2 Previous Clinical Trials
90 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a current primary care patient in Eskenazi Health.
You have a depressive disorder at screening.

Who else is applying?

What state do they live in?
Indiana50.0%
Maine50.0%
How old are they?
18 - 6550.0%
65+50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria66.7%
Met criteria33.3%
What site did they apply to?
IUPUI Department of Psychology100.0%
How many prior treatments have patients received?
2100.0%