Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)
NCT ID: NCT03675776
Last Updated: 2020-07-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
50 participants
INTERVENTIONAL
2018-10-30
2019-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rapastinel 450mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Rapastinel 225mg
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Placebo
Placebo (prefilled syringe, weekly IV administration).
Placebo
Placebo (prefilled syringe, weekly IV administration).
Interventions
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Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Placebo
Placebo (prefilled syringe, weekly IV administration).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Naurex, Inc, an affiliate of Allergan plc
INDUSTRY
Responsible Party
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Principal Investigators
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Jenna Hoogerheyde
Role: STUDY_DIRECTOR
Allergan
Locations
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Bugát Pál Hospital, Clinexpert
Gyöngyös, , Hungary
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
Maynds Tower Mental Clinic
Shibuya-ku, , Japan
Himeno Tomomi Clinic
Shinagawa-ku, , Japan
Shinjuku Research Park Clinic
Shinjuku-ku, , Japan
Ohwa Mental Clinic
Toshima-ku, , Japan
Okehazama Hospital Fujita Kokoro Care Center
Toyoake, , Japan
Yokohama Onoecho Clinic
Yokohama, , Japan
Centrum Medyczne Luxmed Sp.z o.o.
Lublin, , Poland
Federal State Budgetary Research Institution "Mental Health Science Center"
Moscow, , Russia
Yaroslavl Regional Psychiatric Hospital
Yaroslavl, , Russia
MENTUM, s.r.o.
Bratislava, , Slovakia
Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia
Bratislava, , Slovakia
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
Liptovský Mikuláš, , Slovakia
Psycholine s.r.o.
Rimavská Sobota, , Slovakia
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.
Other Identifiers
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2018-000060-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RAP-MD-30
Identifier Type: -
Identifier Source: org_study_id
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