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

NCT03855865 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: RAP-MD-312018-000063-88
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to 10 mg of Vortixetine and placebo in participants with major depressive disorder (MDD).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at the End of the Double Blind Treatment Period (DBTP) (end of Week 6)

  The MADRS, a clinician-rated scale, will be used to assess depressive symptomatology. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item will be scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.

  Baseline to end of Week 6

Secondary Outcomes (1)

• Change from Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment

  Baseline to Day 1 post-first dose

Study Arms (3)

Rapastinel

EXPERIMENTAL

Rapastinel (450 mg prefilled syringe, weekly intravenous IV administration).

Drug: Rapastinel

Vortioxetine

ACTIVE COMPARATOR

Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).

Drug: Vortioxetine

Placebo

PLACEBO COMPARATOR

Placebo (prefilled syringe, weekly IV administration or oral daily).

Drug: Placebo

Interventions

Rapastinel DRUG

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Rapastinel

Vortioxetine DRUG

Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).

Vortioxetine

Placebo DRUG

Placebo (prefilled syringe, weekly IV administration or oral daily).

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
• 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

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

Interventions

GLYX-13 peptide; Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marc Debelle

  Allergan

  STUDY DIRECTOR

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: February 25, 2019
• First Posted: February 27, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.