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Antidepressant

Antidepressant Medications for Type 2 Diabetes

Phase 2
Waitlist Available
Led By Jesse C Stewart, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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
  • Depression
  • Dysthymia
  • Prediabetes
  • Insulin Resistance

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemoglobin A1c at 6 Months
Secondary outcome measures
Depressive Symptoms
Homeostatic Model of Assessment-Insulin Resistance (HOMA-IR) Score at 6 Months

Side effects data

From 2021 Phase 2 trial • 216 Patients • NCT02458690
2%
Emergency department visit for depression/suicidal ideation
2%
Hospitalization for depression/suicidal ideation
1%
Petechiae on hand/wrist due to blood pressure cuff inflation during brachial FMD assessment
1%
Passive suicidal ideation
1%
Suspected drug overdose
1%
Diarrhea following study-initiated suicidal ideation
100%
80%
60%
40%
20%
0%
Study treatment Arm
eIMPACT
Usual Care

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: eIMPACT-DM interventionExperimental Treatment3 Interventions
eIMPACT-DM is a 6-month, modernized, collaborative, stepped care intervention consisting of (1) computerized and telephonic cognitive-behavioral therapy for depression and (2) select antidepressant medications included in an algorithm optimized for diabetes risk reduction. It is a collaborative care intervention in which a multidisciplinary team delivers established depression treatments consistent with patient preference. It uses a stepped, flexible, treat-to-target approach that modernizes the IMPACT intervention by harnessing technology to minimize staff and space requirements. Interventions are Good Days Ahead, Problem Solving Treatment in Primary Care, and select FDA-approved antidepressants. The treatment team consists of a depression clinical specialist, a supervising MD with expertise in primary care and IMPACT, and the patients' primary care providers (PCPs).
Group II: Active ControlActive Control1 Intervention
Active Control (AC) consists of depression education (study staff), symptom monitoring (study staff), and primary care for depression (clinical staff).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antidepressant Medications
2015
Completed Phase 2
~270
Good Days Ahead (GDA)
2020
Completed Phase 2
~50
Problem Solving Treatment in Primary Care (PST-PC)
2015
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,356 Previous Clinical Trials
4,315,020 Total Patients Enrolled
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
983,114 Total Patients Enrolled
Jesse C Stewart, PhDPrincipal InvestigatorIndiana University-Purdue University Indianapolis (IUPUI)
2 Previous Clinical Trials
90 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people will be participating in this experiment at most?

"That is correct. The clinical trial indicated on clinicaltrials.gov is still looking for patients to enroll. This particular study was posted on October 14th, 2020 and updated January 18th, 2022. They are currently recruiting for 64 participants from 1 site."

Answered by AI

Are people currently enrolling in this trial?

"Yes, the information on clinicaltrials.gov indicates that this study is actively looking for candidates. The trial was first posted on 10/14/2020 and was most recently updated on 1/18/2022. The clinical trial is searching for 64 patients across 1 sites."

Answered by AI

Are there any other scientific investigations that have looked at Antidepressant Medications?

"Currently, there are 62 different ongoing clinical trials studying antidepressant medications. Of these studies, 16 are in phase 3. The majority of the trials are taking place in Bridgewater, New jersey; however, there are a total of 334 research sites for this topic."

Answered by AI

Are there long-term repercussions to taking antidepressant medications?

"Antidepressant medications received a score of 2, as there is some data supporting safety, but none yet for efficacy."

Answered by AI

For what purpose are Antidepressant Medications typically prescribed?

"Commonly, individuals with attention deficit hyperactivity disorder (ADHD) are treated by Antidepressant Medications. However, these same medications can be applied to other issues such as seasonal affective disorder, smoking cessation, and withdrawal."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Maine
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
IUPUI Department of Psychology
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk
Jesse Stewart 2020. "eIMPACT-DM Pilot Trial: Depression Treatment to Reduce Diabetes Risk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04437485.
~10 spots leftby Apr 2025
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