Clinical trial NCT03675776: Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Keywords: Depression
Lead sponsor: Naurex, Inc, an affiliate of Allergan plc
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


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
* 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:

  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

Primary outcomes:
measure: Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Treatment (End of Week 6).
timeFrame: Baseline to end of Week 6
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score at 1 Day After First Dose of Treatment
timeFrame: Baseline to 1 Day post-first dose
Other outcomes:
Locations:
city: Gyongyos
country: Hungary
facility: Bugát Pál Hospital, Clinexpert
city: Ichigayatamachi
country: Japan
facility: Himorogi Psychiatric Institute
city: Kawasaki-shi
country: Japan
facility: Kishiro Mental Clinic
city: Kobe-shi
country: Japan
facility: Tatsuta Clinic
city: Kumamoto-shi
country: Japan
facility: Medical corporation Sato-Kai Yuge Hospital
city: Kyoto-shi
country: Japan
facility: Sagaarashiyama-Tanaka Clinic
city: Meguro-ku
country: Japan
facility: Senzoku psychosomatic Medicine Clinic
city: Sapporo-shi
country: Japan
facility: Higashi Sapporo Mental Clinic
city: Setagaya-ku
country: Japan
facility: Sangenjaya Neurology- Psychosomatic Clinic
city: Shibuya-ku
country: Japan
facility: Yoyogi Mental Clinic
city: Shibuya-ku
country: Japan
facility: Maynds Tower Mental Clinic
city: Shinagawa-ku
country: Japan
facility: Himeno Tomomi Clinic
city: Shinjuku-ku
country: Japan
facility: Shinjuku Research Park Clinic
city: Toshima-ku
country: Japan
facility: Ohwa Mental Clinic
city: Toyoake-city
country: Japan
facility: Okehazama Hospital Fujita Kokoro Care Center
city: Yokohama-shi
country: Japan
facility: Yokohama Onoecho Clinic
city: Lublin
country: Poland
facility: Centrum Medyczne Luxmed Sp.z o.o.
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Research Institution "Mental Health Science Center"
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Psychiatric Hospital
city: Bratislava
country: Slovakia
facility: MENTUM, s.r.o.
city: Bratislava
country: Slovakia
facility: Vavrusova Consulting s.r.o. Neštátna Psychiatrická ambulancia
city: Liptovsky Mikulas
country: Slovakia
facility: Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš
city: Rimavska Sobota
country: Slovakia
facility: Psycholine s.r.o.
Study officials:
affiliation: Allergan
name: Jenna Hoogerheyde
role: STUDY_DIRECTOR
References: