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

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ClinicalTrials.gov Identifier: NCT03668600
Recruitment Status : Enrolling by invitation
First Posted : September 12, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE August 23, 2018
Estimated Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
Count of participants experiencing one or more Treatment emergent adverse events (TEAs) [ Time Frame: NDA submission date to 2 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03668600 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Official Title  ICMJE An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
Brief Summary Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depressive Disorder, Major
Intervention  ICMJE Drug: Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Study Arms  ICMJE Experimental: Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Intervention: Drug: Rapastinel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 10, 2018)
1800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2021
Estimated Primary Completion Date February 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03668600
Other Study ID Numbers  ICMJE RAP-MD-99
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Naurex, Inc, an affiliate of Allergan plc
Study Sponsor  ICMJE Naurex, Inc, an affiliate of Allergan plc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert Hayes, PhD Allergan
PRS Account Naurex, Inc, an affiliate of Allergan plc
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP