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

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Allergan

Status and phase

Terminated
Phase 3

Conditions

Depressive Disorder, Major

Treatments

Drug: Rapastinel
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03675776
2018-000060-29 (EudraCT Number)
RAP-MD-30

Details and patient eligibility

About

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).

Enrollment

50 patients

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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 3 patient groups, including a placebo group

Rapastinel 450mg
Experimental group
Description:
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Treatment:
Drug: Rapastinel
Rapastinel 225mg
Experimental group
Description:
Rapastinel (prefilled syringe, weekly intravenous IV administration).
Treatment:
Drug: Rapastinel
Placebo
Placebo Comparator group
Description:
Placebo (prefilled syringe, weekly IV administration).
Treatment:
Drug: Placebo

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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