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Trial record 15 of 134 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03668600
Recruitment Status : Enrolling by invitation
First Posted : September 12, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Long-term Extended Access Protocol for Rapastinel as Adjunctive or Monotherapy Treatment in Patients With Major Depressive Disorder
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Drug: 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668600


  Show 74 Study Locations
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
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Study Director: Robert Hayes, PhD Allergan

Additional Information:
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Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03668600     History of Changes
Other Study ID Numbers: RAP-MD-99
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naurex, Inc, an affiliate of Allergan plc:
Depression

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms