Antidepressant Discontinuation in Treatment Resistant Depression

NCT ID: NCT03786614

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2024-12-31

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.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Discontinuation of serotonergic antidepressants

Intervention Type: OTHER

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.

Continuation arm

This group will continue taking serotonergic antidepressants which is the standard care of treatment.

Group Type: ACTIVE_COMPARATOR

Continuation of serotonergic medications

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Rifaat S. El-Mallakh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rifaat S. El-Mallakh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville, Department of Psychiatry and Behavioral Sciences

Locations

University of Louisville, Department of Psychiatry and Behavioral Sciences

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lucas Miozza

Role: CONTACT

lgmioz01@louisville.edu

502-588-0678

Facility Contacts

Lucas Miozza

Role: primary

lgmioz01@louisville.edu

502-588-0678

Other Identifiers

18.1351

Identifier Type: -

Identifier Source: org_study_id