Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)

Phase 3

Terminated

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Rapastinel

• Registration Number: NCT03668600
• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Brief Summary

Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-23
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Primary Completion: 2019-07-03
• Study Completion: 2019-07-03
• Status Verified: 2020-07
• Results First Submitted: 2020-07-01
• Results First Submitted QC: 2020-07-01
• Last Update Submitted: 2020-07-01
• Results First Posted: 2020-07-17
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Completion of lead-in study
• Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator

Exclusion Criteria

• Suicide risk, as determined by meeting any of the following criteria:

  1. A suicide attempt within the past year
  2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study
  3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted.

• At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator

• Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation

• Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rapastinel	Rapastinel	Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)

Primary Outcome Measures

Name	Time	Method
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)	Up to 45 Weeks	A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Trial Locations

Locations (73)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Harmonex Neuroscience Research; 🇺🇸 Dothan, Alabama, United States

NoesisPharma; 🇺🇸 Phoenix, Arizona, United States

Woodland International Research Group; 🇺🇸 Little Rock, Arkansas, United States

Woodland Research Northwest; 🇺🇸 Rogers, Arkansas, United States

California Pharmaceutical Research Institute, Inc; 🇺🇸 Anaheim, California, United States

Southern California Research LLC.; 🇺🇸 Beverly Hills, California, United States

ATP Clinical Research Inc.; 🇺🇸 Costa Mesa, California, United States

ProScience Research Group; 🇺🇸 Culver City, California, United States

Pharmacology Research Institute; 🇺🇸 Los Alamitos, California, United States

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