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

Allergan

Status and phase: Withdrawn; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Vortioxetine; Drug: Rapastinel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03855865

RAP-MD-31

2018-000063-88 (EudraCT Number)

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups, including a placebo group

Rapastinel

Experimental group

Description:

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

Treatment:

Drug: Rapastinel

Vortioxetine

Active Comparator group

Description:

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

Treatment:

Drug: Vortioxetine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo