Clinical trial NCT02932943: A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 stess disorder
  7. MDD with psychotic features
* Significant suicide risk, as judged by the Investigator.

Primary outcomes:
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial
timeFrame: Baseline and 3 Weeks
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score
timeFrame: Baseline and Day 8
measure: Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
timeFrame: Baseline and Day 21
measure: Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
timeFrame: Baseline and Day 8
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Southern California Research LLC.
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research Inc.
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC
state: California
city: Lemon Grove
country: United States
facility: Synergy San Diego
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
state: California
city: Temecula
country: United States
facility: Viking Clinical Research
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical
state: California
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Florida
city: Lakeland
country: United States
facility: Meridien Research
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Watertown
country: United States
facility: Adams Clinical Trials
state: Massachusetts
city: Las Vegas
country: United States
facility: Altea Research
state: Nevada
city: Mount Kisco
country: United States
facility: Bioscience Research
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center, LLC
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Canton
country: United States
facility: Neuro-Behavioral Clinical Research, Inc
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center LLC
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc
state: Tennessee
city: Austin
country: United States
facility: Donald J. Garcia, Jr., MD, PA
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
city: Bellevue
country: United States
facility: NorthWest Clinical Research Center
state: Washington
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: