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Anti-depressant

TEA + Lexapro for Irritable Bowel Syndrome (Home-TEA Trial)

Phase 2 & 3
Recruiting
Led By Borko Nojkov, MD
Research Sponsored by University of Michigan
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 daily for 14 weeks
Awards & highlights

Home-TEA Trial Summary

This trial will compare the effectiveness of two active treatments (TEA and escitalopram) to a sham comparator on abdominal pain.

Who is the study for?
This trial is for adults with ongoing, symptomatic Irritable Bowel Syndrome with Constipation (IBS-C) who experience abdominal pain not relieved by other treatments. Participants should have had symptoms at least once a week in the past three months and must not be pregnant or planning pregnancy. Exclusions include those with certain medical conditions, recent surgery, or using specific medications like SSRIs and NSAIDs.Check my eligibility
What is being tested?
The study tests the effectiveness of Transcutaneous Electrical Acustimulation (TEA) and Lexapro against a sham control on relieving abdominal pain in IBS-C patients. Participants will be randomly assigned to receive either TEA, Lexapro, or an inactive treatment to compare outcomes.See study design
What are the potential side effects?
Possible side effects from TEA may include skin irritation where electrodes are placed. Lexapro can cause nausea, sleepiness, weight changes, dry mouth, sexual side effects and increased sweating. It's important to note that individual reactions to treatments can vary.

Home-TEA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey
Change in global abdominal pain
Secondary outcome measures
Cathartics
Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety
Change in Hospital Anxiety and Depression Scale (HADS) - Depression
+6 more

Home-TEA Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: TEA at location CExperimental Treatment1 Intervention
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Group II: TEA at location AExperimental Treatment1 Intervention
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Group III: Escitalopram treatmentExperimental Treatment1 Intervention
This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.
Group IV: TEA at location BPlacebo Group1 Intervention
The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TEA
2017
Completed Phase 3
~370
Lexapro
2001
Completed Phase 4
~280

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Irritable Bowel Syndrome (IBS) include Transcutaneous Electrical Acupoint Stimulation (TEA) and Selective Serotonin Reuptake Inhibitors (SSRIs) like Escitalopram. TEA works by electrically stimulating specific acupoints to modulate the nervous system and increase endorphin release, which helps alleviate pain. Escitalopram increases serotonin levels in the brain and gut, aiding in pain modulation and mood improvement. These treatments are significant for IBS patients as they address both the physical and psychological aspects of the condition, offering a comprehensive approach to managing symptoms.
How Serotonin Level Fluctuation Affects the Effectiveness of Treatment in Irritable Bowel Syndrome.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,813 Previous Clinical Trials
6,383,438 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
790 Patients Enrolled for Irritable Bowel Syndrome
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,348 Previous Clinical Trials
648,001 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
50 Patients Enrolled for Irritable Bowel Syndrome
National Center for Complementary and Integrative Health (NCCIH)NIH
837 Previous Clinical Trials
670,213 Total Patients Enrolled
8 Trials studying Irritable Bowel Syndrome
1,339 Patients Enrolled for Irritable Bowel Syndrome

Media Library

Lexapro (Anti-depressant) Clinical Trial Eligibility Overview. Trial Name: NCT05519683 — Phase 2 & 3
Irritable Bowel Syndrome Research Study Groups: TEA at location C, TEA at location A, Escitalopram treatment, TEA at location B
Irritable Bowel Syndrome Clinical Trial 2023: Lexapro Highlights & Side Effects. Trial Name: NCT05519683 — Phase 2 & 3
Lexapro (Anti-depressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05519683 — Phase 2 & 3
Irritable Bowel Syndrome Patient Testimony for trial: Trial Name: NCT05519683 — Phase 2 & 3
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