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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rapastinel

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

Group Type EXPERIMENTAL

Rapastinel

Intervention Type DRUG

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Vortioxetine

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

Group Type ACTIVE_COMPARATOR

Vortioxetine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Rapastinel

Rapastinel (prefilled syringe, weekly intravenous IV administration).

Intervention Type DRUG

Vortioxetine

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No