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

Phase 3

Terminated

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Rapastinel; Drug: Placebo

• Registration Number: NCT03675776
• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-18
• Study Start: 2018-10-30
• Primary Completion: 2019-07-11
• Study Completion: 2019-07-11
• Status Verified: 2020-07
• Results First Submitted: 2020-07-10
• Results First Submitted QC: 2020-07-10
• Last Update Submitted: 2020-07-10
• Results First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (23)

MENTUM, s.r.o.; 🇸🇰 Bratislava, Slovakia

Yokohama Onoecho Clinic; 🇯🇵 Yokohama-shi, Japan

Medical corporation Sato-Kai Yuge Hospital; 🇯🇵 Kumamoto-shi, Japan

Sagaarashiyama-Tanaka Clinic; 🇯🇵 Kyoto-shi, Japan

Yoyogi Mental Clinic; 🇯🇵 Shibuya-ku, Japan

Sangenjaya Neurology- Psychosomatic Clinic; 🇯🇵 Setagaya-ku, Japan

Tatsuta Clinic; 🇯🇵 Kobe-shi, Japan

Kishiro Mental Clinic; 🇯🇵 Kawasaki-shi, Japan

Psycholine s.r.o.; 🇸🇰 Rimavska Sobota, Slovakia

Senzoku psychosomatic Medicine Clinic; 🇯🇵 Meguro-ku, Japan

Federal State Budgetary Research Institution "Mental Health Science Center"; 🇷🇺 Moscow, Russian Federation

Himorogi Psychiatric Institute; 🇯🇵 Ichigayatamachi, Japan

Shinjuku Research Park Clinic; 🇯🇵 Shinjuku-ku, Japan

Bugát Pál Hospital, Clinexpert; 🇭🇺 Gyongyos, Hungary

Ohwa Mental Clinic; 🇯🇵 Toshima-ku, Japan

Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia; 🇸🇰 Bratislava, Slovakia

Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš; 🇸🇰 Liptovsky Mikulas, Slovakia

Centrum Medyczne Luxmed Sp.z o.o.; 🇵🇱 Lublin, Poland

Yaroslavl Regional Psychiatric Hospital; 🇷🇺 Yaroslavl, Russian Federation

Higashi Sapporo Mental Clinic; 🇯🇵 Sapporo-shi, Japan

Maynds Tower Mental Clinic; 🇯🇵 Shibuya-ku, Japan

Himeno Tomomi Clinic; 🇯🇵 Shinagawa-ku, Japan

Okehazama Hospital Fujita Kokoro Care Center; 🇯🇵 Toyoake-city, Japan