A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

Allergan

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Rapastinel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02943564

RAP-MD-02

Details and patient eligibility

About

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Enrollment: 658 patients

Sex: All

Ages: 18 to 65 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 no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
• 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: Quadruple Blind

---

658 participants in 3 patient groups, including a placebo group

Rapastinel 225 mg

Experimental group

Description:

Rapastinel 225 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.

Treatment:

Drug: Rapastinel

Rapastinel 450 mg

Experimental group

Description:

Rapastinel 450 mg weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.

Treatment:

Drug: Rapastinel

Placebo

Placebo Comparator group

Description:

Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.

Treatment:

Drug: Placebo