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Antidepressant

Antidepressant Discontinuation for Treatment Resistant Depression

N/A
Recruiting
Led By Rifaat S. El-Mallakh, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be a man or woman 18 to 70 years of age, inclusive.
Subjects must have a current Treatment-Resistant Depression as defined below.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline and every visit [every 4 weeks] to the end of the study. [6 months]
Awards & highlights

Study Summary

This trial is testing whether it's better to keep or stop taking a certain type of antidepressant when symptoms don't go away. People will also have the chance to get genetic testing to see if it helps.

Who is the study for?
This trial is for adults aged 18-70 with major depressive disorder who haven't responded to two different antidepressant treatments over a period of 2-4 years. They must be medically stable and not pregnant, planning pregnancy, or breastfeeding. Excluded are those with bipolar, schizophrenia, autism, intellectual disability, recent substance abuse (except nicotine or cannabis), or at risk of suicide.Check my eligibility
What is being tested?
The study compares the impact on depression symptoms between patients who stop taking serotonergic antidepressants and those who continue them. It also explores if genetic testing for serotonin transporter genes can improve treatment outcomes in treatment-resistant depression.See study design
What are the potential side effects?
Potential side effects from discontinuing serotonergic medications may include withdrawal symptoms such as mood swings, irritability, agitation, dizziness, sensory disturbances (like electric shock sensations), confusion, anxiety, headache and insomnia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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My depression has not improved despite treatment.
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I am not pregnant and agree to prevent pregnancy during the study.
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I am between 18 and 70 years old.
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My depression has not improved despite treatment.
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I am not pregnant and agree to prevent pregnancy during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline and every visit [every 4 weeks] to the end of the study. [6 months]
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline and every visit [every 4 weeks] to the end of the study. [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
Comparing the difference of response as measured by the Montgomery-Åsberg Depression Rating Scale [MADRS] between both arms.
Comparing the difference of response as measured by the Montgomery-Åsberg Depression Rating Scale [MADRS] between subjects with low expressing alleles and high expressing alleles of the serotonin gene transporter.
Secondary outcome measures
Evaluating changes in levels of anxiety as measured by the Hamilton Anxiety Rating Scale [HAM-A] between both arms.
Evaluating the difference of response as measured by the Columbia Suicide Severity Rating Scale [C-SSRS] between both arms.

Trial Design

2Treatment groups
Active Control
Group I: Discontinuation armActive Control1 Intervention
This group will be discontinued from serotonergic antidepressants and shifting them to other categories of antidepressants, i.e., medications that work through dopamine or nor-epinephrine, or by reducing the serotonin signal rather than increasing synaptic serotonin, as might be accomplished with low dose, sub-anti-psychotic doses of some second-generation anti-psychotics.
Group II: Continuation armActive Control1 Intervention
This group will continue taking serotonergic antidepressants which is the standard care of treatment.

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,650 Total Patients Enrolled
Rifaat S. El-Mallakh, MDPrincipal Investigator - University of Louisville, Department of Psychiatry and Behavioral Sciences
University Of Louisville Physicians, Inc., University of Louisville Hospital
University Of Illinois College Of Medicine (Medical School)
University Of Ct School Of Medicine (Residency)

Media Library

Serotonergic Antidepressants (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT03786614 — N/A
Major Depressive Disorder Research Study Groups: Discontinuation arm, Continuation arm
Major Depressive Disorder Clinical Trial 2023: Serotonergic Antidepressants Highlights & Side Effects. Trial Name: NCT03786614 — N/A
Serotonergic Antidepressants (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03786614 — N/A
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT03786614 — N/A

Frequently Asked Questions

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

Are there any restrictions regarding eligibility for this medical experiment?

"This medical trial is seeking 30 individuals with a unipolar depression diagnosis between the ages of 18 and 70 to take part. Criteria for enrolment include: Treatment-Resistant Depression as defined, usage of serotonergic antidepressants (serotonin reuptake inhibitor or monoamine oxidase inhibitor) over 2 - 4 years coupled with two previous medication failures in their current episode, a MADRS score equal to or more than 25, meeting criteria for major depressive disorder via MINI assessment, medically stable status confirmed by doctor visit, negative urine pregnancy test at screening if female along with an agreement to not become pregnant during treatment period; signed informed consent"

Answered by AI

Are enrollments still being accepted for this research project?

"Affirmative, the information on clinicaltrials.gov shows that this trial is actively recruiting patients. This experiment was initially uploaded on June 20th 2019 and was most recently updated on May 21st 2022. The study requires 30 individuals to be recruited from a single location."

Answered by AI

How many participants are enrolled in this clinical research study?

"Affirmative. Evidence from clinicaltrials.gov highlights that this trial is currently enrolling participants, with the first listing being posted on June 20th 2019 and last updated May 21st 2022. At present, 30 patients need to be sourced from one medical facility."

Answered by AI

Does this clinical experiment accept senior citizens as participants?

"According to the prerequisites of this trial, any participant must be over 18 years old but not older than 70."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Indiana
Kentucky
How old are they?
18 - 65
What site did they apply to?
University of Louisville, Department of Psychiatry and Behavioral Sciences
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
0
3+

Why did patients apply to this trial?

To get help with depression and seek medicine for it. I am in need of income & am interested in help for my depression.
PatientReceived no prior treatments
I've been on so many different antidepressants since I was 12 yrs old. Ive tried every drug you can think of, supplements, probiotics, meditation.
PatientReceived 1 prior treatment
I’ve tried numerous SSRI’s over the past years and they work for awhile then just stop working.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is the trial for? How's long do screenings take? Have you had any good to results yet?
PatientReceived 2+ prior treatments
Just a side note…I must have clicked on ‘next’ by accident on the last question. I had planned to repeat a segment I had originally put in the introduction letter about medications, talk therapy, etc. that I’ve gone through but was unaware of the question following the introduction letter when I was forwarded to this question. For this question I’d like to know the trial length, would I report in person to trial staff, does this trial involve talk therapy or medications and if there is compensation?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Louisville, Department of Psychiatry and Behavioral Sciences: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Antidepressant Discontinuation in Treatment Resistant Depression
Rifaat S. El-Mallakh 2019. "Antidepressant Discontinuation in Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03786614.
All > Depression Cincinnati
~3 spots leftby Dec 2024
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