RECRUITING

Antidepressant Discontinuation in Treatment Resistant Depression

Conditions

Treatment Resistant Depression serotonergic antidepressants short form of serotonin transporter

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to compare the effects on depressive symptoms of subjects who discontinue serotonergic antidepressants (a certain type of antidepressant, such as Prozac, that works on serotonin receptors in the brain) with the effects on depressive symptoms of subjects who continue to take serotonergic antidepressants. During this study, subjects will also be presented with the opportunity to undergo genetic testing for the serotonin gene transporter which has a short or long form. This is being done because it has been demonstrated that genetic testing improves outcome while treating treatment-resistant depression.

Official Title

Antidepressant Discontinuation in Treatment Resistant Depression

Quick Facts

Study Start:2019-06-20

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03786614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Lucas Miozza

CONTACT

502-588-0678

lgmioz01@louisville.edu

Principal Investigator

Rifaat S. El-Mallakh, MD

PRINCIPAL_INVESTIGATOR

University of Louisville, Department of Psychiatry and Behavioral Sciences

Study Locations (Sites)

University of Louisville, Department of Psychiatry and Behavioral Sciences

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: University of Louisville

Rifaat S. El-Mallakh, MD, PRINCIPAL_INVESTIGATOR, University of Louisville, Department of Psychiatry and Behavioral Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-20

Study Completion Date2024-12

Study Record Updates

Study Start Date2019-06-20

Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

treatment resistant depression
serotonergic antidepressants
short form of serotonin transporter

Additional Relevant MeSH Terms

Treatment Resistant Depression