Antidepressant Discontinuation in Treatment Resistant Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03786614|
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : June 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Other: Discontinuation of serotonergic antidepressants Other: Continuation of serotonergic medications||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The person performing the data collection (rater) will be blind to the randomization of the patient for the entire duration of the study|
|Official Title:||Antidepressant Discontinuation in Treatment Resistant Depression|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||July 2022|
Active Comparator: Discontinuation arm
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.
Other: Discontinuation of serotonergic antidepressants
Discontinuation of serotonergic antidepressants and possibly shift to other antidepressant categories that were proven to be effective in treating depression such as pramipexole, bupropion, quetiapine, lurasidone, brexpipazole. Additionally, subjects will have access to other treatment measures of treating treatment resistant depression.
Active Comparator: Continuation arm
This group will continue taking serotonergic antidepressants which is the standard care of treatment.
Other: Continuation of serotonergic medications
Continuation of serotonergic medications which is the standard care of treatment. Additionally, subjects will have access to other treatment measures of treating treatment resistant depression.
- Comparing the difference of response as measured by the Montgomery-Åsberg Depression Rating Scale [MADRS] between both arms. [ Time Frame: From baseline and every visit [every 4 weeks] to the end of the study. [6 months] ]The MADRS is a psychiatric scale to assess the depressive symptoms from the patient's prospective. The final score ranges from 0 to 60 with 0 indicating no depression and higher scores indicating greater depression. The final scores will be evaluated with a non-paired, two-tailed t-test.
- 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. [ Time Frame: End of study [6 months]. ]Genetic testing for the serotonin transporter gene will be done for every patient in the study. All subjects with homozygous and heterozygous low expression alleles will be combined as one group, and all high expression subjects will be the other group. One-way ANOVAs will be conducted for each genotype group, with genotype group as the independent variable (IV) and MADRS scores as the dependent variables (DV).
- Evaluating changes in levels of anxiety as measured by the Hamilton Anxiety Rating Scale [HAM-A] between both arms. [ Time Frame: From baseline and every visit [every 4 weeks] to the end of the study. [6 months] ]The HAM-A will be collected to assess changes in anxiety levels from the patient's prospective. It ranges from 0 to 56 with greater scores indicating more anxiety. The final scores will be evaluated with a non-paired, two-tailed t-test.
- Evaluating the difference of response as measured by the Columbia Suicide Severity Rating Scale [C-SSRS] between both arms. [ Time Frame: From baseline and every visit [every 4 weeks] to the end of the study. [6 months] ]The C-SSRS is a psychiatric scale to assess suicidality. It ranges from 0 to 5 with 0 indicating no suicidal ideas and higher scores indicating greater suicidal ideas. The final scores will be evaluated with a non-paired, two-tailed t-test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786614
|Contact: Sharon Nussemail@example.com|
|United States, Kentucky|
|University of Louisville, Department of Psychiatry and Behavioral Sciences||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Sharon Nuss 502-588-0678 firstname.lastname@example.org|
|Principal Investigator: Rif S. El-Mallakh, MD|
|Sub-Investigator: Ziad A. Ali, MD|
|Principal Investigator:||Rifaat S. El-Mallakh, MD||University of Louisville, Department of Psychiatry and Behavioral Sciences|