Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)

Phase 3

Terminated

Brief Summary: 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).

Recruitment & Eligibility

Inclusion Criteria

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
1. Schizophrenia spectrum or other psychotic disorder
2. Bipolar or related disorder
3. Major neurocognitive disorder
4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
5. Dissociative disorder
6. Posttraumatic stress disorder
7. MDD with psychotic features
Significant suicide risk, as judged by the investigator

Arm && Interventions

Group	Intervention	Description
Rapastinel 450mg	Rapastinel	Rapastinel (prefilled syringe, weekly intravenous IV administration).
Rapastinel 225mg	Rapastinel	Rapastinel (prefilled syringe, weekly intravenous IV administration).
Placebo	Placebo	Placebo (prefilled syringe, weekly IV administration).

Primary Outcome Measures

Name	Time	Method
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).	Baseline to 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment	Baseline to 1 Day post-first dose	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.

Locations (23): Bugát Pál Hospital, Clinexpert
🇭🇺
Gyongyos, Hungary
Himorogi Psychiatric Institute
🇯🇵
Ichigayatamachi, Japan
Kishiro Mental Clinic
🇯🇵
Kawasaki-shi, Japan
Tatsuta Clinic
🇯🇵
Kobe-shi, Japan
Medical corporation Sato-Kai Yuge Hospital
🇯🇵
Kumamoto-shi, Japan
Sagaarashiyama-Tanaka Clinic
🇯🇵
Kyoto-shi, Japan
Senzoku psychosomatic Medicine Clinic
🇯🇵
Meguro-ku, Japan
Higashi Sapporo Mental Clinic
🇯🇵
Sapporo-shi, Japan
Sangenjaya Neurology- Psychosomatic Clinic
🇯🇵
Setagaya-ku, Japan
Yoyogi Mental Clinic
🇯🇵
Shibuya-ku, Japan
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Bugát Pál Hospital, Clinexpert
🇭🇺Gyongyos, Hungary