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

Primary Purpose

Depressive Disorder, Major

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rapastinel
Placebo
Sponsored by
Naurex, Inc, an affiliate of Allergan plc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bugát Pál Hospital, Clinexpert
  • Himorogi Psychiatric Institute
  • Kishiro Mental Clinic
  • Tatsuta Clinic
  • Medical corporation Sato-Kai Yuge Hospital
  • Sagaarashiyama-Tanaka Clinic
  • Senzoku psychosomatic Medicine Clinic
  • Higashi Sapporo Mental Clinic
  • Sangenjaya Neurology- Psychosomatic Clinic
  • Yoyogi Mental Clinic
  • Maynds Tower Mental Clinic
  • Himeno Tomomi Clinic
  • Shinjuku Research Park Clinic
  • Ohwa Mental Clinic
  • Okehazama Hospital Fujita Kokoro Care Center
  • Yokohama Onoecho Clinic
  • Centrum Medyczne Luxmed Sp.z o.o.
  • Federal State Budgetary Research Institution "Mental Health Science Center"
  • Yaroslavl Regional Psychiatric Hospital
  • MENTUM, s.r.o.
  • Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia
  • Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
  • Psycholine s.r.o.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Rapastinel 450mg

Rapastinel 225mg

Placebo

Arm Description

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Placebo (prefilled syringe, weekly IV administration).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 17, 2018
Last Updated
July 10, 2020
Sponsor
Naurex, Inc, an affiliate of Allergan plc
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1. Study Identification

Unique Protocol Identification Number
NCT03675776
Brief Title
Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Business decision to stop the program.
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
July 11, 2019 (Actual)
Study Completion Date
July 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Naurex, Inc, an affiliate of Allergan plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapastinel 450mg
Arm Type
Experimental
Arm Description
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Arm Title
Rapastinel 225mg
Arm Type
Experimental
Arm Description
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (prefilled syringe, weekly IV administration).
Intervention Type
Drug
Intervention Name(s)
Rapastinel
Intervention Description
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (prefilled syringe, weekly IV administration).
Primary Outcome Measure Information:
Title
Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
Description
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.
Time Frame
Baseline to end of Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment
Description
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.
Time Frame
Baseline to 1 Day post-first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Hoogerheyde
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Bugát Pál Hospital, Clinexpert
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Himorogi Psychiatric Institute
City
Ichigayatamachi
ZIP/Postal Code
162-0843
Country
Japan
Facility Name
Kishiro Mental Clinic
City
Kawasaki-shi
ZIP/Postal Code
214-0014
Country
Japan
Facility Name
Tatsuta Clinic
City
Kobe-shi
ZIP/Postal Code
651-0097
Country
Japan
Facility Name
Medical corporation Sato-Kai Yuge Hospital
City
Kumamoto-shi
ZIP/Postal Code
861-8002
Country
Japan
Facility Name
Sagaarashiyama-Tanaka Clinic
City
Kyoto-shi
ZIP/Postal Code
616-8421
Country
Japan
Facility Name
Senzoku psychosomatic Medicine Clinic
City
Meguro-ku
ZIP/Postal Code
152-0012
Country
Japan
Facility Name
Higashi Sapporo Mental Clinic
City
Sapporo-shi
ZIP/Postal Code
003-0003
Country
Japan
Facility Name
Sangenjaya Neurology- Psychosomatic Clinic
City
Setagaya-ku
ZIP/Postal Code
154-0004
Country
Japan
Facility Name
Yoyogi Mental Clinic
City
Shibuya-ku
ZIP/Postal Code
151-0051
Country
Japan
Facility Name
Maynds Tower Mental Clinic
City
Shibuya-ku
ZIP/Postal Code
151-0053
Country
Japan
Facility Name
Himeno Tomomi Clinic
City
Shinagawa-ku
ZIP/Postal Code
141-0032
Country
Japan
Facility Name
Shinjuku Research Park Clinic
City
Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Ohwa Mental Clinic
City
Toshima-ku
ZIP/Postal Code
170-0002
Country
Japan
Facility Name
Okehazama Hospital Fujita Kokoro Care Center
City
Toyoake-city
ZIP/Postal Code
470-1168
Country
Japan
Facility Name
Yokohama Onoecho Clinic
City
Yokohama-shi
ZIP/Postal Code
231-0015
Country
Japan
Facility Name
Centrum Medyczne Luxmed Sp.z o.o.
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Facility Name
Federal State Budgetary Research Institution "Mental Health Science Center"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Yaroslavl Regional Psychiatric Hospital
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
MENTUM, s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Facility Name
Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia
City
Bratislava
ZIP/Postal Code
85101
Country
Slovakia
Facility Name
Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
City
Liptovsky Mikulas
ZIP/Postal Code
03123
Country
Slovakia
Facility Name
Psycholine s.r.o.
City
Rimavska Sobota
ZIP/Postal Code
97901
Country
Slovakia

12. IPD Sharing Statement

Links:
URL
http://www.allerganclinicaltrials.com/
Description
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.

Learn more about this trial

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

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