Enrolling Clinical Studies
MAJOR DEPRESSION CLINICAL TRIAL
This study will evaluate the efficacy and safety of Zelquistinel (GATE-251), an oral medication for the reduction of symptoms of major depressive disorder in adults.
Requirements:
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Men or women between 18 to 64 years of age.
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Subjects not using nicotine products (vapes) or any drugs (marijuana, cocaine, etc.).
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Subjects with BMI no more than 40 kg/m².
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Subjects with a diagnosis of Major Depression Disorder (single or current episode).
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If the subject had a single depressive episode, the duration must be between 3 weeks and 18 months.
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No subjects with bipolar disorder, antisocial personality disorder, OCD, ADHD, or psychotic disorder.
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Subjects must be medically stable based on physical examination, medical history, ECG, and lab results.
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Female subjects of childbearing potential must use an acceptable birth control method.
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No subjects with evidence of treatment-resistant MDD to two or more different medications.
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No subjects taking antipsychotics, mood stabilizers, sedatives, stimulants, or benzodiazepines.
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Subjects must not have taken any experimental treatment for depression within the past 12 months.
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No subjects with renal issues, unstable diabetes, or HbA1c over 7% during Visit 1.
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No subjects with ongoing HIV, COVID-19, Hepatitis B or C, or at risk of suicidal behavior.
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No subjects currently working a night shift or who may be required to work a night shift.
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No malignancy in the last five years (cancer).
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Subjects must not be enrolled in another clinical trial or have completed a study in the last 90 days.
Study Duration:
This study contains a total of 8 in-clinic visits with 2 Polysomnography at home during 3 consecutives nights and 7 telephone contacts in a period of 4 months
Compensation:
This study will pay $150 per in-clinic visit. $150 for using the Polysomnography and $50 per Telephone contact. A total of $1,700 for completing the study.