Comparing effects of stopping versus continuing antidepressants in treatment-resistant depression
Antidepressant Discontinuation in Treatment Resistant Depression
This study is testing whether stopping or continuing antidepressants helps people aged 18 to 70 with treatment-resistant depression feel better after being on the medication for 2 to 4 years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT03786614 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact on depressive symptoms in individuals with treatment-resistant depression who either discontinue or continue taking serotonergic antidepressants. Participants will undergo genetic testing for the serotonin gene transporter, which may influence treatment outcomes. The study will involve subjects aged 18 to 70 who have been on these medications for 2 to 4 years and have not responded to previous treatments. The goal is to determine if stopping the medication leads to better outcomes compared to continuing it.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of major depressive disorder who have been on serotonergic antidepressants for 2 to 4 years and have not responded to at least two previous medication trials.
Not a fit: Patients who are not currently taking serotonergic antidepressants or those with other forms of depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment strategies for patients with treatment-resistant depression.
How similar studies have performed: Other studies have indicated that genetic testing can improve treatment outcomes in similar populations, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be a man or woman 18 to 70 years of age, inclusive. * Subject must meet criteria for a major depressive disorder as confirmed by the Mini International Neuropsychiatric Interview \[MINI\]. * Subjects must have a current Treatment-Resistant Depression as defined below. * Subjects must have been taking serotonergic antidepressants (serotonin reuptake inhibitor or monoamine oxidase inhibitor) for at least 2 years but not more than 4 years, and have failed 2 previous medication trial for the current episode. Current Montgomery-Åsberg Depression Rating Scale \[MADRS\] score must be equal to or more than 25. * Subject must be medically stable. * Female subjects must have a negative urine pregnancy test at screening, and agree to avoid pregnancy during the study. * Each subject must sign an informed consent form indicating that he/she understands the purpose of the study and the procedures required and are willing to participate in the study. * Subject must be able to participate in symptom measurement. Exclusion Criteria: * Subject has a current Diagnostic and Statistical Manual of Mental Disorders-5 \[DSM-5\] diagnosis of bipolar disorder or has a positive screening for bipolar disorder by Mini International Neuropsychiatric Interview \[MINI\] or Mood Disorder Questionnaire \[MDQ\]. * Subject has a current DSM-5 diagnosis of schizophrenia, schizoaffective disorder, autistic disorder, or intellectual disability. * Subject has a substance use disorder (except for nicotine or cannabis) within 3 months prior to screening or has a positive drug screen test for any recreational drugs at the time of screening with the exception of Cannabis. * Subject has evidence of any clinically significant, unstable medical problems that may create a safety risk for a subject, interfere with study participation, or make results difficult to interpret. * Subject is at imminent risk of suicide according to the investigator's clinical judgment and/or a Columbia-Suicide Severity Rating Scale (C-SSRS) 3 or more at any time in the study. * Subject is a woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study. * Subject has any condition (according to the investigator) for which participation will not be the best interest for the subject or it can prevent, limit or confound the protocol-specified assessments.
Where this trial is running
Louisville, Kentucky
- University of Louisville, Department of Psychiatry and Behavioral Sciences — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Rifaat S. El-Mallakh, MD — University of Louisville, Department of Psychiatry and Behavioral Sciences
- Study coordinator: Lucas Miozza
- Email: lgmioz01@louisville.edu
- Phone: 502-588-0678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.