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

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03675776
• Other study ID #: RAP-MD-30
• Secondary ID: 2018-000060-29
• Status: Terminated
• Phase: Phase 3
• Start date: October 30, 2018
• Est. completion date: July 11, 2019

Study information

• Verified date: July 2020
• Source: Naurex, Inc, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: July 11, 2019
• Est. primary completion date: July 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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 ß-human chorionic gonadotropin (ß-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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Rapastinel
Rapastinel (prefilled syringe, weekly intravenous IV administration).
• Placebo
Placebo (prefilled syringe, weekly IV administration).

Locations

Country	Name	City	State
Hungary	Bugát Pál Hospital, Clinexpert	Gyongyos
Japan	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	Maynds Tower Mental Clinic	Shibuya-ku
Japan	Yoyogi 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-city
Japan	Yokohama Onoecho Clinic	Yokohama-shi
Poland	Centrum Medyczne Luxmed Sp.z o.o.	Lublin
Russian Federation	Federal State Budgetary Research Institution "Mental Health Science Center"	Moscow
Russian Federation	Yaroslavl Regional Psychiatric Hospital	Yaroslavl
Slovakia	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	Liptovsky Mikulas
Slovakia	Psycholine s.r.o.	Rimavska Sobota

Sponsors (1)

Lead Sponsor	Collaborator
Naurex, Inc, an affiliate of Allergan plc

Countries where clinical trial is conducted

Hungary,  Japan,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to end of Week 6
Secondary	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.	Baseline to 1 Day post-first dose

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.