Major Depressive Disorder; Treatment Resistant Adjunctive Study for Adults

Treatment Resistant Depression Study

Study Specific Details:

ALTO (Mirapex and Zofran) vs Placebo – This is a phase 2b, randomized, double blind, placebo-controlled trial.
10-week treatment period over 17-weeks.
Visit frequency: approx. every 1-2 weeks.
Participant is reimbursed for their time and travel.

Male or Female, ages 19-75.
Currently meets a primary diagnosis of MDD per the DSM-5 criteria.
BMI 17-41 kg, inclusive.
Moderate to severe symptoms of depression.
Must have failed (< 50% improvement) to at least 2, but no more than 5 antidepressants in current major depressive episode, with adequate dose ad duration (6-weeks or longer, doses defined by the ATRQ).
Psychotherapy is allowed if initiated for at least 3 months before screening and is not expected to change in frequency or type through the duration of the study.
GLP-1 receptor agonist is allowed, provided it has been unchanged for the past 3 months and remains at the same dose and frequency throughout the study.

Has failed 5 or more antidepressant treatments (which includes TMS) during the current depressive episode despite and adequate dose and duration.
Severe impediment to vision, hearing, comprehension, and/or hand movement that may interfere with participant’s ability to perform trial tasks.
Active suicidal ideation at screening.
Suicide attempt within 6 months of screening.
Diagnosis of PTSD is allowed as long it is not the primary diagnosis and they do not currently have symptoms.
Diagnosis of bipolar or a psychotic disorder or symptoms.
Moderate to severe alcohol use disorder or current moderate to severe substance use disorder, other then nicotine in the past 3 months.
Excluded medications: Psychostimulants, antipsychotics, mood stabilizers, and anticonvulsants (psychiatric treatment) are not allowed during the study period.
Has received electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, more than 2 treatments with ketamine, arketamine, and/or esketamine in the current depressive episode (a new depressive episode occurs if the so not meet DSM-5 criteria for MDD for 2 consecutive months).

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