- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675776
Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)
July 10, 2020 updated by: Naurex, Inc, an affiliate of Allergan plc
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gyongyos, Hungary, 3200
- Bugát Pál Hospital, Clinexpert
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Ichigayatamachi, Japan, 162-0843
- Himorogi Psychiatric Institute
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Kawasaki-shi, Japan, 214-0014
- Kishiro Mental Clinic
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Kobe-shi, Japan, 651-0097
- Tatsuta Clinic
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Kumamoto-shi, Japan, 861-8002
- Medical corporation Sato-Kai Yuge Hospital
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Kyoto-shi, Japan, 616-8421
- Sagaarashiyama-Tanaka Clinic
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Meguro-ku, Japan, 152-0012
- Senzoku Psychosomatic Medicine Clinic
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Sapporo-shi, Japan, 003-0003
- Higashi Sapporo Mental Clinic
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Setagaya-ku, Japan, 154-0004
- Sangenjaya Neurology- Psychosomatic Clinic
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Shibuya-ku, Japan, 151-0051
- Yoyogi Mental Clinic
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Shibuya-ku, Japan, 151-0053
- Maynds Tower Mental Clinic
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Shinagawa-ku, Japan, 141-0032
- Himeno Tomomi Clinic
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Shinjuku-ku, Japan, 169-0073
- Shinjuku Research Park Clinic
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Toshima-ku, Japan, 170-0002
- Ohwa Mental Clinic
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Toyoake-city, Japan, 470-1168
- Okehazama Hospital Fujita Kokoro Care Center
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Yokohama-shi, Japan, 231-0015
- Yokohama Onoecho Clinic
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Lublin, Poland, 20-109
- Centrum Medyczne Luxmed Sp.z o.o.
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Moscow, Russian Federation, 115522
- Federal State Budgetary Research Institution "Mental Health Science Center"
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Yaroslavl, Russian Federation, 150003
- Yaroslavl Regional Psychiatric Hospital
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Bratislava, Slovakia, 82007
- MENTUM, s.r.o.
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Bratislava, Slovakia, 85101
- Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia
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Liptovsky Mikulas, Slovakia, 03123
- Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
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Rimavska Sobota, Slovakia, 97901
- PsychoLine s.r.o.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Schizophrenia spectrum or other psychotic disorder
- Bipolar or related disorder
- Major neurocognitive disorder
- 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
- Dissociative disorder
- Posttraumatic stress disorder
- MDD with psychotic features
- Significant suicide risk, as judged by the investigator
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Rapastinel 450mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
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Rapastinel (prefilled syringe, weekly intravenous IV administration).
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Experimental: Rapastinel 225mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
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Rapastinel (prefilled syringe, weekly intravenous IV administration).
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Placebo Comparator: Placebo
Placebo (prefilled syringe, weekly IV administration).
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Placebo (prefilled syringe, weekly IV administration).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
Time Frame: Baseline to end of Week 6
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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.
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Baseline to end of Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment
Time Frame: Baseline to 1 Day post-first dose
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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.
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Baseline to 1 Day post-first dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2018
Primary Completion (Actual)
July 11, 2019
Study Completion (Actual)
July 11, 2019
Study Registration Dates
First Submitted
September 17, 2018
First Submitted That Met QC Criteria
September 17, 2018
First Posted (Actual)
September 18, 2018
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAP-MD-30
- 2018-000060-29 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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