The study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Placebo (prefilled syringe, weekly IV administration).
Bugát Pál Hospital, Clinexpert
Gyöngyös, Hungary
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time frame: Baseline to end of Week 6
Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment
The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Time frame: Baseline to 1 Day post-first dose
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Himorogi Psychiatric Institute
Ichigayatamachi, Japan
Kishiro Mental Clinic
Kawasaki-shi, Japan
Tatsuta Clinic
Kobe, Japan
Medical corporation Sato-Kai Yuge Hospital
Kumamoto, Japan
Sagaarashiyama-Tanaka Clinic
Kyoto, Japan
Senzoku psychosomatic Medicine Clinic
Meguro-ku, Japan
Higashi Sapporo Mental Clinic
Sapporo, Japan
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-ku, Japan
Yoyogi Mental Clinic
Shibuya-ku, Japan
...and 13 more locations