Clinical trial NCT03786614: Antidepressant Discontinuation in Treatment Resistant Depression
Official title: Antidepressant Discontinuation in Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Resistant Depression
Keywords: treatment resistant depression
serotonergic antidepressants
short form of serotonin transporter
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Comparing the difference of response as measured by the Montgomery-Åsberg Depression Rating Scale [MADRS] between both arms.
timeFrame: From baseline and every visit [every 4 weeks] to the end of the study. [6 months]
measure: 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.
timeFrame: End of study [6 months].
Secondary outcomes:
measure: Evaluating changes in levels of anxiety as measured by the Hamilton Anxiety Rating Scale [HAM-A] between both arms.
timeFrame: From baseline and every visit [every 4 weeks] to the end of the study. [6 months]
measure: Evaluating the difference of response as measured by the Columbia Suicide Severity Rating Scale [C-SSRS] between both arms.
timeFrame: From baseline and every visit [every 4 weeks] to the end of the study. [6 months]
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville, Department of Psychiatry and Behavioral Sciences
state: Kentucky
Study officials:
affiliation: University of Louisville, Department of Psychiatry and Behavioral Sciences
name: Rifaat S. El-Mallakh, MD
role: PRINCIPAL_INVESTIGATOR
References: