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

NCT03675776 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: RAP-MD-302018-000060-29
• Study Type: interventional
• Target: 50
• Locations: 5 countries
• Sites: 23

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).

Conditions

Depressive Disorder, Major

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment

  Baseline to 1 Day post-first dose

Study Arms (3)

Rapastinel 450mg

EXPERIMENTAL

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Drug: Rapastinel

Rapastinel 225mg

EXPERIMENTAL

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Drug: Rapastinel

Placebo

PLACEBO COMPARATOR

Placebo (prefilled syringe, weekly IV administration).

Drug: Placebo

Interventions

Rapastinel DRUG

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Rapastinel 225mg; Rapastinel 450mg

Placebo DRUG

Placebo (prefilled syringe, weekly IV administration).

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naurex, Inc, an affiliate of Allergan plc: lead

Study Sites (23)

Bugát Pál Hospital, Clinexpert

Gyöngyös, 3200, Hungary

Location

Himorogi Psychiatric Institute

Ichigayatamachi, 162-0843, Japan

Location

Kishiro Mental Clinic

Kawasaki-shi, 214-0014, Japan

Location

Tatsuta Clinic

Kobe, 651-0097, Japan

Location

Medical corporation Sato-Kai Yuge Hospital

Kumamoto, 861-8002, Japan

Location

Sagaarashiyama-Tanaka Clinic

Kyoto, 616-8421, Japan

Location

Senzoku psychosomatic Medicine Clinic

Meguro-ku, 152-0012, Japan

Location

Higashi Sapporo Mental Clinic

Sapporo, 003-0003, Japan

Location

Sangenjaya Neurology- Psychosomatic Clinic

Setagaya-ku, 154-0004, Japan

Location

Yoyogi Mental Clinic

Shibuya-ku, 151-0051, Japan

Location

Maynds Tower Mental Clinic

Shibuya-ku, 151-0053, Japan

Location

Himeno Tomomi Clinic

Shinagawa-ku, 141-0032, Japan

Location

Shinjuku Research Park Clinic

Shinjuku-ku, 169-0073, Japan

Location

Ohwa Mental Clinic

Toshima-ku, 170-0002, Japan

Location

Okehazama Hospital Fujita Kokoro Care Center

Toyoake, 470-1168, Japan

Location

Yokohama Onoecho Clinic

Yokohama, 231-0015, Japan

Location

Centrum Medyczne Luxmed Sp.z o.o.

Lublin, 20-109, Poland

Location

Federal State Budgetary Research Institution "Mental Health Science Center"

Moscow, 115522, Russia

Location

Yaroslavl Regional Psychiatric Hospital

Yaroslavl, 150003, Russia

Location

MENTUM, s.r.o.

Bratislava, 82007, Slovakia

Location

Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia

Bratislava, 85101, Slovakia

Location

Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš

Liptovský Mikuláš, 03123, Slovakia

Location

Psycholine s.r.o.

Rimavská Sobota, 97901, Slovakia

Location

Related 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.

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

GLYX-13 peptide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Jenna Hoogerheyde

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: October 30, 2018
• Primary Completion: July 11, 2019
• Study Completion: July 11, 2019
• Last Updated: July 28, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Locations

SL (4); RU (2); HU (1); JP (15); PL (1)